A Multi-center, Randomized, Open-label and Positive Controlled Phase II Clinical Trial to Assess Efficacy and Safety of Ypeginterferon Alfa-2b in HBeAg Positive Patients With Chronic Hepatitis B
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 205
- Locations
- 39
- Primary Endpoint
- Efficacy
Study Overview
Brief Summary
This study is a multi-center, randomized, open-label and positive controlled Phase II Clinical trial to assess efficacy and safety of Ypeginterferon alfa-2b, once a week, in 3 dose-groups: 90mcg, 135mcg and 180mcg, respectively, for treatment of chronic hepatitis B characterized by HBeAg positivity, with Pegasys 180mcg/week as positive control. It is aimed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase III trials, and generate pharmacokinetic data of Ypeginterferon alfa-2b in hepatitis B patients to satisfy regulatory requirements.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age:18~60 years.
- •Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the cessation of treatment.
- •Serum HBsAg positive for at least 6 months.
- •Serum HBeAg positive with HBV DNA ≥20,000IU/ml.
- •2×ULN≤ALT≤10×ULN at screening(ULN=upper limit of normal).
Exclusion Criteria
- •Pregnant or lactating women.
- •Mental disorder or physical disability.
- •Interferon treatment history or using nucleos(t)ide analogue for chronic hepatitis B treatment within the previous 6 months.
- •WBC<3000/mm3, or ANC <1500/mm3, or PLT <90,000/mm
- •Co-infection with HAV, HIV, HCV, HDV, HEV.
- •Both HBsAg and anti-HBs are positive, or both HBeAg and anti-HBe are positive at screening.
- •Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease.
- •Evidence of hepatic decompensation.
- •History of hypothyroidism or current treatment for thyroid disease.
- •Uncontrolled significant chronic medical conditions other than chronic hepatitis B, or other conditions which in the opinion of the investigator preclude enrollment into the study.
Arms & Interventions
Group 1
Ypeginterferon alfa-2b 90mcg per week
Intervention: Ypeginterferon alfa-2b (Drug)
Group 2
Ypeginterferon alfa-2b 135mcg per week
Intervention: Ypeginterferon alfa-2b (Drug)
Group 3
Ypeginterferon alfa-2b 180mcg per week
Intervention: Ypeginterferon alfa-2b (Drug)
Group 4
Pegasys 180mcg per week
Intervention: Peginterferon alfa-2a (Drug)
Outcomes
Primary Outcomes
Efficacy
Time Frame: week 24 from treatment start
* Average of HBV DAN decline level at week 24. * Proportion of patients with HBeAg undetectable and HBeAg seroconversion at week 24.
Secondary Outcomes
- Efficacy(week 12, 24, 48 from treatment start and week 24 after treatment)