A Study on Optimizing the Treatment in HBeAg Positive CHB Patients With Response Guide Treatment (RGT) Method.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 265
- Primary Endpoint
- Efficacy: Quantitative HBsAG reduction (proportion of patients with HBsAG reduction)
Study Overview
Brief Summary
This open-label, multi-center study will evaluate the effect on the quantitative HBsAg reduction of peginterferon alfa-2a [PEGASYS] in patients with HBeAg positive chronic hepatitis B. Patients will receive PEGASYS 180 mcg sc once weekly. After 24 weeks of treatment, rapid responders will receive another 24 weeks of treatment. After 24 weeks of treatment, slow responders will be randomized to another 24 or 72 weeks of PEGASYS monotherapy, or to 72 weeks PEGASYS plus 36 weeks adefovir (10 mg, po once daily, starting from week 29 of PEGASYS treatment). The anticipated time on study drug is >2 years.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients >/=18 years of age
- •HBeAg positive chronic hepatitis B
- •Compensated liver disease
Exclusion Criteria
- •Patients who had previously received treatment of drugs with activity against HBV within 6 months prior to study start
- •Antiviral, anti-neoplastic or immunomodulatory treatment
- •Co-infection with active hepatitis A, hepatitis C, hepatitis D, or HIV
- •Evidence of decompensated liver disease
- •Chronic liver disease other than viral hepatitis
Arms & Interventions
D
Intervention: peginterferon alfa-2a [PEGASYS] (Drug)
A
Intervention: peginterferon alfa-2a [PEGASYS] (Drug)
B
Intervention: peginterferon alfa-2a [PEGASYS] (Drug)
C
Intervention: peginterferon alfa-2a [PEGASYS] (Drug)
D
Intervention: Adefovir (Drug)
Outcomes
Primary Outcomes
Efficacy: Quantitative HBsAG reduction (proportion of patients with HBsAG reduction)
Time Frame: Weeks 72, 96, 120
Secondary Outcomes
- Safety: Adverse Events(From baseline to Week 120)
- Proportion of patients achieving HBeAG seroconversion and HBV DNA </=100000 copies/ml(Weeks 24, 48, 72, 96, 120)