Hepatitis B, Chronic Clinical Trial
Official title:
An Open Label Study Evaluating Safety and the Effect of PEGASYS® on HBV DNA Levels in Patients With HBeAg-positive and HBeAg-negative Chronic Hepatitis B
Verified date | April 2016 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | Estonia:State Agency of Medicines of Estonia |
Study type | Interventional |
This single arm study will evaluate the efficacy and safety of PEGASYS in treatment-naive Baltic patients with HBeAg-positive chronic HBV. All patients will receive PEGASYS 180 micrograms s.c. once weekly. Following 48 weeks of treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Status | Completed |
Enrollment | 38 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - adult patients, 18-70 years of age; - HBeAg positive, HBsAg positive for >=6 months; - anti-HBs negative; - HBV DNA >500,000 copies/mL. Exclusion Criteria: - previous antiviral or interferon-based therapy for CHB; - evidence of decompensated liver disease; - chronic liver disease other than viral hepatitis; - co-infection with active hepatitis A, C or D virus; - co-infection with human immunodeficiency virus (HIV). |
Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Estonia, Latvia, Lithuania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with HBV DNA <100,000 copies/mL | Week 72 | No | |
Secondary | HBV DNA <400 copies/mL, HBsAg seroconversion, ALT normalization, sustained HBe seroconversion. | Weeks 48 and 72 | No | |
Secondary | AEs, laboratory parameters. | Throughout study | No |
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