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Efficacy and Safety of Ypeginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B

NCT01143662 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2013-02-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ypeginterferon alfa-2b

sc, qw, for 48 weeks.

DRUG

Peginterferon alfa-2a

sc, qw, for 48 weeks.

Sponsors & Collaborators

  • Peking University First Hospital

    collaborator OTHER

  • Xiamen Amoytop Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Wang Guiqiang, MD, PhD · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-04-30
Completion
2012-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01143662 on ClinicalTrials.gov