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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02791269




Registration number
NCT02791269
Ethics application status
Date submitted
31/05/2016
Date registered
6/06/2016
Date last updated
6/02/2017

Titles & IDs
Public title
A Study of Peginterferon Alfa-2a in Participants With Chronic Hepatitis B Virus (HBV) in an Expanded Access Program
Scientific title
Expanded Access Program of PEGASYS® (Peg Interferon Alpha-2a 40 KD) in Patients With HBeAg-Positive And HBeAg-Negative Chronic Hepatitis B
Secondary ID [1] 0 0
ML19295
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

Experimental: HBeAg Negative Participants - HBeAg negative participants will receive peginterferon alfa-2a 180 micrograms (mcg) subcutaneous (SC) injection once weekly (QW) for 48 weeks followed by a 24 weeks treatment-free follow-up period.

Experimental: HBeAg Positive Participants - HBeAg Positive participants will receive peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.


Treatment: Drugs: Peginterferon alfa-2a
180 mcg SC injection QW for 48 weeks.

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

Outcomes
Primary outcome [1] 0 0
Number of HBeAg Positive Participants With Hepatitis B Virus-deoxy Ribonucleic Acid (HBV-DNA) Less Than (<) 100,000 Copies Per Milliliter (Copies/mL) - HBV-DNA was assessed in plasma samples using quantitative Roche polymerase chain reaction (PCR) or Taqman tests.
Timepoint [1] 0 0
End of 24-weeks follow-up (Week 72)
Primary outcome [2] 0 0
Number of Participants With HBV-DNA <20,000 Copies/mL - HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests.
Timepoint [2] 0 0
End of 24-weeks follow-up (Week 72)
Secondary outcome [1] 0 0
Number of Participants With HBV-DNA <400 Copies/mL - HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests.
Timepoint [1] 0 0
Week 48 (end of treatment) and Week 72 (end of follow-up)
Secondary outcome [2] 0 0
Number 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). Both HBeAg positive and negative participants were HBsAg positive at baseline and absence of HBsAg (seroconversion) was analyzed.
Timepoint [2] 0 0
Week 48 (end of treatment) and Week 72 (end of follow-up)
Secondary outcome [3] 0 0
Number of Participants With Normalization of Alanine Aminotransferase (ALT) Level - ALT 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 level increases. Normal ALT level = less than upper limit of normal (40 units per liter).
Timepoint [3] 0 0
Week 48 (end of treatment) and Week 72 (end of follow-up)
Secondary outcome [4] 0 0
Number of Participants With HBeAg Seroconversion - HBeAg seroconversion for HBeAg positive participants was defined as the loss of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe).
Timepoint [4] 0 0
Week 48 (end of treatment) and Week 72 (end of follow-up)

Eligibility
Key inclusion criteria
- Non-cirrhotic participants

- Hepatitis B surface antigen (HBsAg) positive for at least 6 months

- Hepatitis B surface antibody (anti-HBs) negative

- Elevated serum alanine aminotransferase (ALT) greater than (>) upper limit of normal
(ULN) but less than or equal to (</=) 10 times of ULN

- HBeAg positive participants: HBV DNA > 500,000 copies/mL, HBeAg negative participants:
HBV DNA >100,000 copies/mL by polymerase chain reaction (PCR)

- Participants with chronic hepatitis B (CHB) who are treatment-naive

- No previous antiviral treatment with interferon (IFN: standard or pegylated) or with a
nucleoside analogue

- For women of childbearing potential: negative urine or serum pregnancy test documented
within the 24-hour period prior to the first dose of test drug. Willingness to use
reliable contraception during the study and for 3 months after treatment completion
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous antiviral or IFN-based therapy for CHB before enrolment

- Pregnant or breast feeding women participants

- Evidence of decompensated liver disease

- Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human
immunodeficiency virus (HIV)

- History or other evidence of a medical condition associated with chronic liver disease
other than viral hepatitis

- Previous or current hepatocellular carcinoma

- History of or other evidence of bleeding from esophageal varices or other conditions
consistent with decompensated liver disease

- Alpha-fetoprotein levels of >100 nanograms (ng)/mL

- Severe psychiatric disease

- History of a severe seizure disorder or current anticonvulsant use

- History of immunologically mediated disease, chronic pulmonary disease associated with
functional limitation, severe cardiac disease, major organ transplantation or other
evidence of severe illness, malignancy, or any other conditions which would make the
participant, in the opinion of the investigator, unsuitable for the study

- Thyroid disease uncontrolled by prescribed medications

- Evidence of severe retinopathy

- Alcohol intake more than 3 standard drinks per day for men and 2 standard drinks per
day for women

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Hamilton
Country [3] 0 0
New Zealand
State/province [3] 0 0
New Plymouth
Country [4] 0 0
New Zealand
State/province [4] 0 0
Riccarton, Christchurch
Country [5] 0 0
New Zealand
State/province [5] 0 0
Rotorua
Country [6] 0 0
New Zealand
State/province [6] 0 0
Whangarei

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

Ethics approval
Ethics application status

Summary
Brief summary
This is an expanded access, multicenter, national, open-label, and non-randomized study to
analyze the safety of peginterferon alfa-2a in participants with hepatitis B e antigen
(HBeAg) positive and HBeAg negative chronic HBV infection. All participants will receive 48
weeks treatment of peginterferon alfa-2a monotherapy, followed by a 24 week treatment-free
follow-up period.
Trial website
https://clinicaltrials.gov/show/NCT02791269
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