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

Xiamen Amoytop Biotech Co., Ltd.39 sites in 1 country205 target enrollmentJuly 2010

ConditionsChronic Hepatitis B

InterventionsYpeginterferon alfa-2b Peginterferon alfa-2a

DrugsYpeginterferon alfa-2b Peginterferon alfa-2a

Overview

Phase: Phase 2
Intervention: Ypeginterferon alfa-2b
Conditions: Chronic Hepatitis B
Sponsor: Xiamen Amoytop Biotech Co., Ltd.
Enrollment: 205
Locations: 39
Primary Endpoint: Efficacy
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

July 2010

End Date

April 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Xiamen Amoytop Biotech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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.