A Phase 3, Randomized, Multi-center, Active-controlled, Open-label Study to Evaluate the Efficacy and Safety of Peginterferon Alfa-2b (40kD, Y Shape) in Chinese Chronic Hepatitis B Patients.

Xiamen Amoytop Biotech Co., Ltd.43 sites in 1 country820 target enrollmentMarch 2013

ConditionsChronic Hepatitis B

InterventionsYpeginterferon alfa-2b Pegasys

DrugsYpeginterferon alfa-2b Pegasys

Overview

Phase: Phase 3
Intervention: Ypeginterferon alfa-2b
Conditions: Chronic Hepatitis B
Sponsor: Xiamen Amoytop Biotech Co., Ltd.
Enrollment: 820
Locations: 43
Primary Endpoint: Proportion of patients with HBeAg seroconversion at week72
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is aimed to assess the efficacy and safety of Peginterferon alfa-2b (40kD, Y-shape), in a dose of 180μg/week, in chronic hepatitis B patients, and collects sufficient evidences for the listed of the studied drug.

Registry

clinicaltrials.gov

Start Date

March 2013

End Date

August 2015

Last Updated

10 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\~65 years.
•Serum HBsAg or HBV DNA positive for at least 6 months.
•Serum HBsAg and HBeAg are both positive, HBV DNA ≥ 20,000IU/ml at screening.
•2×ULN≤ ALT ≤10×ULN at screening (ULN=upper limit of normal).
•Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the treatment.

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.
•ANC \< 1500/mm3, or PLT \< 90,000/mm
•Co-infection with HAV, HIV, HCV, HDV, or HEV.
•Both of HBsAg and anti-HBs are positive, or both of HBeAg and anti-HBe are positive at screening.
•Child-Pugh ≥ B, or other evidence of hepatitis decompensation (e.g.: prothrombin time prolonged more than 3 seconds, TBil \> 2ULN, Alb\<35g/L).
•Chronic hepatitis caused by any other reason except hepatitis B.
•Hepatocarcinoma or suffering from any other malignant tumor.
•Not well-controlled endocrine diseases (e.g.: thyroid dysfunction, diabetes mellitus)

Arms & Interventions

Ypeginterferon Alfa-2b

Intervention: Ypeginterferon alfa-2b

Pegasys

Intervention: Pegasys

Outcomes

Primary Outcomes

Proportion of patients with HBeAg seroconversion at week72

Time Frame: 24 weeks after the cessation of treatment

Secondary Outcomes

Average of HBV DNA decline level at week 12, 24,48 and 72(week 12, 24, 48 and 72 from treatment starting)
Proportion of patients with ALT normalization at week 12,24, 48 and 72.(week 12, 24, 48 and 72 from treatment starting)
Proportion of Patients with HBeAg seroconversion at week 12,24,48(week 12, 24, 48 from treatment starting)
Proportion fo patients with HBeAg undetectable at week 12, 24, 48, and 72.(week 4, 12, 24, 48 and 72 from treatment starting)
Average of HBsAg decline level at week 12, 24, 48 and 72, and Proportion of patients with HBsAg undetectable and HBsAg seroconversion at week 12, 24, 48 and 72.(week 12, 24, 48 and 72 from treatment starting)