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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01855997




Registration number
NCT01855997
Ethics application status
Date submitted
8/05/2013
Date registered
17/05/2013
Date last updated
5/04/2017

Titles & IDs
Public title
A Study to Collect Blood Biomarker Samples From Participants With Chronic Hepatitis B (CHB) Who Received Treatment With Pegasys (Peginterferon Alfa-2a) ± Nucleoside/Nucleotide Analogue
Scientific title
A Phase IV, Blood Sample Collection Study For Exploratory Evaluation of the Association of Single Nucleotide Polymorphisms With Treatment Responses From Subjects With HBe-Antigen Positive or Negative Chronic Hepatitis B, Who Received Therapy for Hepatitis B With Peginterferon Alfa-2a 40kD (Peg-IFN) ± Nucleos(t)Ide Analogue
Secondary ID [1] 0 0
GV28855
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Peg-IFN alfa-2a

Adult CHB Participants Treated With Peg-IFN Alfa-2a - Adult participants with CHB infection, and who have completed at least 24 weeks of Peg-IFN alfa-2a with/without nucleoside analogue therapy and at least 24 weeks of follow-up, will be included. Participants will be recruited from Roche clinical trials or general practice; no treatment will be administered in this non-interventional study.


Treatment: Drugs: Peg-IFN alfa-2a
Participants received Peg-IFN alfa-2a prior to enrollment for at least 24 weeks. Dosing was chosen according to standard of care or at the discretion of the treating physician.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Single Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance =24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Model - Genome-wide association study (GWAS) approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of the antibody to HBeAg (anti-HBe). HBsAg clearance was defined as the loss of HBsAg, with or without detection of the antibody to HBsAg (anti-HBs). Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Timepoint [1] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [2] 0 0
SNPs Associated With HBeAg Seroconversion or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model - GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Timepoint [2] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [3] 0 0
SNPs Associated With HBeAg Seroconversion or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model - GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Timepoint [3] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [4] 0 0
SNPs Associated With HBeAg Seroconversion or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model - GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Timepoint [4] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [5] 0 0
SNPs Associated With HBeAg Seroconversion Plus Undetectable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Positive CN Population: Additive Model - GWAS approach was used to evaluate association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as HBV DNA level below the lower limit of detection (LLD) of 2000 international units per milliliter (IU/mL). HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Timepoint [5] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [6] 0 0
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model - GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Timepoint [6] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [7] 0 0
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model - GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Timepoint [7] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [8] 0 0
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model - GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Timepoint [8] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [9] 0 0
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Negative Non-East Asian (Non-CN) Population: Additive Model - GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs17037122) was included in the analysis.
Timepoint [9] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [10] 0 0
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population: Dominant Model - GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs17037122) was included in the analysis.
Timepoint [10] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [11] 0 0
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Negative CN Population: Additive Model - GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs2464266) was included in the analysis.
Timepoint [11] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [12] 0 0
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Negative CN Population: Dominant Model - GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Timepoint [12] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [13] 0 0
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Model - GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Timepoint [13] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [14] 0 0
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Model - GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Timepoint [14] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [15] 0 0
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment in Non-CN Population: Additive Model - GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Timepoint [15] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [16] 0 0
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment in Non-CN Population: Dominant Model - GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs17037122) was included in the analysis.
Timepoint [16] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [17] 0 0
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment in CN Population: Additive Model - GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Timepoint [17] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [18] 0 0
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment in CN Population: Dominant Model - GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Timepoint [18] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [19] 0 0
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment: Additive Model - GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Timepoint [19] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [20] 0 0
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment: Dominant Model - GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Timepoint [20] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [21] 0 0
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment in Non-CN Population: Additive Model - GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Timepoint [21] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [22] 0 0
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment in Non-CN Population: Dominant Model - GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Timepoint [22] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [23] 0 0
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment in CN Population: Additive Model - GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Timepoint [23] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [24] 0 0
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment in CN Population: Dominant Model - GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Timepoint [24] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [25] 0 0
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment: Additive Model - GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Timepoint [25] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [26] 0 0
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment: Dominant Model - GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Timepoint [26] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [27] 0 0
SNPs Associated With HBsAg Clearance =24 Weeks Post-Treatment in Non-CN Population: Additive Model - GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs12992677) was included in the analysis.
Timepoint [27] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [28] 0 0
SNPs Associated With HBsAg Clearance =24 Weeks Post-Treatment in Non-CN Population: Dominant Model - GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs12992677) was included in the analysis.
Timepoint [28] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [29] 0 0
SNPs Associated With HBsAg Clearance =24 Weeks Post-Treatment in CN Population: Additive Model - GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs7549785) was included in the analysis.
Timepoint [29] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [30] 0 0
SNPs Associated With HBsAg Clearance =24 Weeks Post-Treatment in CN Population: Dominant Model - GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs7549785) was included in the analysis.
Timepoint [30] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [31] 0 0
SNPs Associated With HBsAg Clearance =24 Weeks Post-Treatment: Additive Model - GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Timepoint [31] 0 0
Single blood sample =24 weeks post-treatment
Primary outcome [32] 0 0
SNPs Associated With HBsAg Clearance =24 Weeks Post-Treatment: Dominant Model - GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs6592052) was included in the analysis.
Timepoint [32] 0 0
Single blood sample =24 weeks post-treatment

Eligibility
Key inclusion criteria
- Adults greater than or equal to (=) 18 years of age

- CHB

- Previously enrolled in a Roche study and treated for CHB for =24 weeks with Peg-IFN ±
nucleoside analogue (lamivudine or entecavir) or Peg-IFN ± nucleotide analogue
(adefovir) and with =24 weeks post-treatment follow-up; or

- Treated in general practice for CHB with Peg-IFN according to standard of care and in
line with the current Summary of Product Characteristics (SmPC)/local labeling who
have no contraindication to Peg-IFN therapy as per local label and have been treated
with Peg-IFN for =24 weeks and have =24 week post-treatment response available at the
time of blood sample collection
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Hepatitis A, hepatitis C, or human immunodeficiency virus (HIV) infection

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Wien
Country [2] 0 0
Bulgaria
State/province [2] 0 0
Sofia
Country [3] 0 0
Bulgaria
State/province [3] 0 0
Varna
Country [4] 0 0
China
State/province [4] 0 0
Beijing
Country [5] 0 0
China
State/province [5] 0 0
Changsha
Country [6] 0 0
China
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This Phase 4 study is designed for the collection of blood biomarker samples from
participants who have completed CHB treatment with at least 24 weeks of a pegylated
interferon alfa-2a (Peg-IFN alfa-2a) containing regimen and at least 24 weeks post-treatment
follow-up. Participants may be enrolled from historical studies supported or sponsored by
Roche, ongoing studies supported or sponsored by Roche, or from general medical practice. The
follow-up of individuals who choose to participate in this study will be in accordance with
the ongoing studies or with the general medical practice of the physician. Data from whole
blood deoxyribonucleic acid (DNA) samples collected in the GV28555 study or available from
previously collected Roche Clinical Repository (RCR) samples will be used for combined
analysis with data from other applicable studies. Procedures will include blood sample
collection (not applicable for participants who previously have consented and donated RCR DNA
samples) and medical record capture.
Trial website
https://clinicaltrials.gov/show/NCT01855997
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications