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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00927082




Registration number
NCT00927082
Ethics application status
Date submitted
16/06/2009
Date registered
23/06/2009
Date last updated
10/02/2016

Titles & IDs
Public title
A Follow-Up Study to WV19432, to Evaluate Long Term Post-Treatment Effects of PEGASYS (Peginterferon Alfa-2a(40KD))in Patients With HBeAg Positive Chronic Hepatitis B
Scientific title
A Follow-up Study to Evaluate the Long-term Post Treatment Effects of Peginterferon Alfa-2a (PEG-IFN) in Patients With HBeAg Positive Chronic Hepatitis B From the Original Study WV19432(NEPTUNE).
Secondary ID [1] 0 0
MV22430
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
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - peginterferon alfa-2a [Pegasys]

Experimental: PEG-IFN 90mcg 24 Wks - Participants received Pegasys (Pegylated interferon alfa-2a [PEG-IFN]) 90 micrograms (mcg) subcutaneously (SC) once a week for 24 weeks in Study WV19432 and entered follow-up (FU) Study MV22430.

Experimental: PEG-IFN 180mcg 24 Wks - Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.

Experimental: PEG-IFN 90mcg 48 Wks - Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.

Experimental: PEG-IFN 180mcg 48 Wks - Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.


Treatment: Drugs: peginterferon alfa-2a [Pegasys]
90 or 180 micrograms/week sc for 24 or 48 weeks in original study (WV19432). No study treatment in long-term post-treatment follow-up study (MV22430)

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

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion. - HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe). Missing values were counted as non-response.
Timepoint [1] 0 0
Annually, for up to 5 years
Primary outcome [2] 0 0
Percentage of Participants With HBsAg Loss - HBsAg loss is defined as the absence of HBsAg (i.e. a negative result for HBsAg). Missing values were counted as non-response.
Timepoint [2] 0 0
Annually, for up to 5 years
Secondary outcome [1] 0 0
Percentage of Participants With HBeAg Loss. - HBeAg loss is defined as the absence of HBeAg (i.e. a negative result for HBeAg). Missing values were counted as non-response.
Timepoint [1] 0 0
Annually, for up to 5 years
Secondary outcome [2] 0 0
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion. - HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs). Missing values were counted as non-response.
Timepoint [2] 0 0
Annually, for up to 5 years
Secondary outcome [3] 0 0
Percentage of Participants With Presence of Anti-Hepatitis B Envelope Antigen (HBe). - The presence of anti-HBe is defined as antibody produced against e antigen in HBeAg. Seroconversion from e antigen to e antibody (anti-HBe) is a predictor of long-term clearance of hepatitis B virus (HBV) in participants undergoing antiviral therapy and indicates lower levels of HBV, and therefore lower infectivity. Missing values were counted as non-response.
Timepoint [3] 0 0
Annually, for up to 5 years
Secondary outcome [4] 0 0
Percentage of Participants With Presence of Anti-HBs - The presence of anti-HBs is defined as antibody produced against HBsAg.It is generally interpreted as indicating recovery and immunity from HBV infection. Missing values were counted as non-response.
Timepoint [4] 0 0
Annually, for up to 5 years
Secondary outcome [5] 0 0
Percentage of Participants With Normalised Alanine Transaminase (ALT) - Alanine Transaminase is an enzyme found mainly in liver and is measured to check if the liver is damaged or diseased. In case of liver damage or disease, the liver releases ALT into the blood stream and the ALT levels increase. Missing values were counted as non-response.
Timepoint [5] 0 0
Annually, for up to 5 years
Secondary outcome [6] 0 0
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 International Unit/Milliliter (IU/mL). - The percentage of participants with HBV-DNA suppression < 20,000 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.
Timepoint [6] 0 0
Annually, for up to 5 years
Secondary outcome [7] 0 0
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 International Unit/Milliliter (IU/mL) - The percentage of participants with HBV-DNA suppression < 2,000 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.
Timepoint [7] 0 0
Annually, for up to 5 years
Secondary outcome [8] 0 0
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 80 International Unit/Milliliter (IU/mL) - The percentage of participants with HBV-DNA suppression < 80 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.
Timepoint [8] 0 0
Annually, for up to 5 years
Secondary outcome [9] 0 0
Quantitative HBsAg - Quantitative HBsAg assay is a diagnostic test for assessing the amount of the HBsAg in chronic Hepatitis B participants. Missing values were counted as non-response.
Timepoint [9] 0 0
Annually, for up to 5 years
Secondary outcome [10] 0 0
Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B - Participants who required additional treatments specifically to treat CHB, associated laboratory test abnormalities and associated symptoms in this long-term observation in the study were reported. Receipt of such treatment did not require participant withdrawal from further participation.
Timepoint [10] 0 0
Up to 5-year FU period
Secondary outcome [11] 0 0
Number of Participants With Clinically Significant Events Related to Chronic Hepatitis B (CHB) - Clinically significant events were defined as one or more of the following: Hepatocellular carcinoma, hepatic decompensation, CHB-related death, hepatic transplant, marked elevation of serum ALT of >10 x upper limit of normal (ULN).
Timepoint [11] 0 0
Up to 5-year FU period
Secondary outcome [12] 0 0
Number of Participants With Marked Laboratory Abnormalities - Marked abnormality of laboratory parameters is defined as the value which is outside the defined reference range of that respective parameter. Roche's following reference ranges for laboratory test parameters were used for the analysis: Hemoglobin (reference range: 110-200 grams/liter[g/L]), White blood cells (WBC) (3.0-18.0 ^10^9/L), Platelets (100-550 ^10^9/L), Neutrophils (1.50-9.25 ^10^9/L), Prothrombin time (PT) Normal ratio (n.d.-2.00), Alkaline phosphatase (0-220 units/liter [U/L]), Alanine aminotransferase (0-110 U/L), Aspartate transaminase (0-80 U/L), Total bilirubin (0-34 micromole/liter [umol/L]), Gamma-glutamyl transpeptidase (GGT) (0-190 U/L), Blood urea nitrogen (BUN) (0.0-14.3 millimole/liter [mmol/L]), Creatinine (0-154 umol/L), Total Protein (55-87 g/L), Albumin (30.0-n.d. g/L), Potassium (2.9-5.8 mmol/L), Sodium (130-150 mmol/L), Calcium (2.00-2.90 mmol/L), Uric acid (0-600 umol/L). It includes marked abnormalities observed during Study WV19432 and FU study MV22430
Timepoint [12] 0 0
Up to 5-year FU period

Eligibility
Key inclusion criteria
- Informed consent for Study WV19432

- Patients who have completed treatment and follow-up on study WV19432
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- As for Study WV19432

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
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)
VIC
Recruitment hospital [1] 0 0
- Fitzroy
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
BA
Country [2] 0 0
Brazil
State/province [2] 0 0
SP
Country [3] 0 0
China
State/province [3] 0 0
Beijing
Country [4] 0 0
China
State/province [4] 0 0
Changsha
Country [5] 0 0
China
State/province [5] 0 0
Guangzhou
Country [6] 0 0
China
State/province [6] 0 0
Shanghai
Country [7] 0 0
Hong Kong
State/province [7] 0 0
Hong Kong
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Seoul
Country [9] 0 0
New Zealand
State/province [9] 0 0
Auckland
Country [10] 0 0
New Zealand
State/province [10] 0 0
Hamilton
Country [11] 0 0
Russian Federation
State/province [11] 0 0
Samara
Country [12] 0 0
Russian Federation
State/province [12] 0 0
St Petersburg
Country [13] 0 0
Russian Federation
State/province [13] 0 0
Stavropol
Country [14] 0 0
Singapore
State/province [14] 0 0
Singapore
Country [15] 0 0
Taiwan
State/province [15] 0 0
Kaohsiung
Country [16] 0 0
Taiwan
State/province [16] 0 0
Taipei
Country [17] 0 0
Taiwan
State/province [17] 0 0
Taoyuan
Country [18] 0 0
Thailand
State/province [18] 0 0
Bangkok
Country [19] 0 0
Thailand
State/province [19] 0 0
Chiang Mai
Country [20] 0 0
Thailand
State/province [20] 0 0
Khon Kaen
Country [21] 0 0
Thailand
State/province [21] 0 0
Songkhla

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is a long-term post-treatment follow-up to study WV19432, which evaluated the
efficacy and safety of PEGASYS in patients with HBeAg positive chronic hepatitis B
(CHB).Patients who received treatment with PEGASYS, and completed follow-up, are eligible to
enter this post-treatment follow-up study. The anticipated time on study was 5 years, and the
target sample size is 100-500 individuals.
Trial website
https://clinicaltrials.gov/show/NCT00927082
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