Hepatitis B, Chronic Clinical Trial
Official title:
A Randomized, Open Label Study to Compare the Effect of Combination Treatment With PEGASYS + Adefovir Dipivoxil Versus PEGASYS Monotherapy on HBV-DNA and ALT Levels in Patients With HBeAg-negative, Chronic Hepatitis B.'
Verified date | November 2016 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | Turkey: Ministry of Health |
Study type | Interventional |
This 3 arm study will compare the efficacy and safety of combination therapy with PEGASYS + adefovir dipivoxil (ADV) versus PEGASYS monotherapy, in HBeAg-negative chronic hepatitis B patients.Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly + ADV 10mg po daily for 48 weeks, followed by ADV 10mg po monotherapy for an additional 48 weeks, and a further 48 week treatment-free follow-up, 2)PEGASYS 180 micrograms sc weekly + ADV 10mg po daily for 48 weeks, followed by a 96 week treatment-free follow-up, or 3)PEGASYS 180 micrograms sc monotherapy weekly for 48 weeks, followed by a 96 week treatment-free follow-up. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.
Status | Completed |
Enrollment | 10 |
Est. completion date | May 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - adult patients, 18-70 years of age; - chronic hepatitis B; - positive HBsAg, positive anti-HBe, negative anti HBsAg, negative HBeAg for at least the prior 6 months; - either nucleoside analogue naive, or has not received IFN-a in the past 6 months. Exclusion Criteria: - positive for hepatitis A, C, D or HIV; - history or other evidence of a medical condition associated with chronic liver disease other than hepatitis B; - antiviral, antineoplastic or immunomodulatory treatment <=6 months prior to first dose of randomized treatment. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Normalization of ALT, and HBV-DNA <400 copies/mL | Week 96 for arm 1; week 48 for arms 2 and 3 | No | |
Primary | HBsAg quantitative loss and anti-HBs seroconversion | Weeks 48, 96 and 144 | No | |
Secondary | AEs, lab parameters, vital signs | Throughtout study | No |
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