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

January 31, 2013 updated by: Xiamen Amoytop Biotech Co., Ltd.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

205

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking University First Hospital
      • Beijing, China
        • Beijing Youan Hospital, Capital Medical University
      • Beijing, China
        • Peking University People's Hospital
      • Beijing, China
        • 302 Military Hospital
      • Beijing, China
        • Beijing Youyi Hospital, capital Medical University
      • Changchun, China
        • First Affiliated Hospital of Jilin University
      • Changsha, China
        • Xiangya Hospital, Central-south University
      • Changsha, China
        • Xiangya Second Hospital, Central-south University
      • Chengdu, China
        • West China Hospital, Sichuan University
      • Chongqing, China
        • Southwest Hospital
      • Fuzhou, China
        • Fuzhou Infectious Disease Hospital
      • Guangzhou, China
        • Guangzhou Eighth People's Hospital
      • Guangzhou, China
        • Nanfang Hospital
      • Guangzhou, China
        • Third Affiliated Hospital of Sun Yat-sen University
      • Guilin, China
        • First Affiliated Hospital of Guangxi Medical University
      • Hangzhou, China
        • First affiliated hospital, Zhejiang University
      • Harbin, China
        • Second Affiliated Hospital of Harbin Medical University
      • Hefei, China
        • First Affiliated Hospital of Anhui Medical University
      • Jinan, China
        • Jinan Infectious Disease Hospital
      • Lanzhou, China
        • First Affiliated Hospital of Lanzhou University
      • Nanchang, China
        • First Affiliated Hospital of Nanchang University
      • Nanjing, China
        • Jiangsu Province Hospital
      • Nanjing, China
        • Second Hospital of Nanjing
      • Nanjing, China
        • 81 Military Hospital
      • Shanghai, China
        • Ruijin Hospital
      • Shanghai, China
        • RenJi Hospital
      • Shanghai, China
        • Shanghai Public Health Clinical Center
      • Shanghai, China
        • Changhai Hospital
      • Shanghai, China
        • Huashan Hospital
      • Shanghai, China
        • 85 Militay Hospital
      • Shenzhen, China
        • Shenzhen Third People's Hospital
      • Shijiazhuang, China
        • Third Affiliated Hospital, Hebei Medical University
      • Taiyuan, China
        • First Affiliated Hospital, Shanxi University
      • Tianjin, China
        • Tianjin Third Central Hospital
      • Wenzhou, China
        • First Affiliated Hospital Of Wenzhou Medical College
      • Wuhan, China
        • Tongji Hospital, Huazhong University of Science&Technology
      • Xian, China
        • Tangdu Hospital, Fourth Military Medical University
      • Zhengzhou, China
        • Henan Provincial People's Hospital
      • Zhengzhou, China
        • First Affiliated Hospital of Zhengzhou University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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/mm3.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1
Ypeginterferon alfa-2b 90mcg per week
Drug: Ypeginterferon alfa-2b
sc, qw, for 48 weeks.
EXPERIMENTAL: Group 2
Ypeginterferon alfa-2b 135mcg per week
Drug: Ypeginterferon alfa-2b
sc, qw, for 48 weeks.
EXPERIMENTAL: Group 3
Ypeginterferon alfa-2b 180mcg per week
Drug: Ypeginterferon alfa-2b
sc, qw, for 48 weeks.
ACTIVE_COMPARATOR: Group 4
Pegasys 180mcg per week
Drug: Peginterferon alfa-2a
sc, qw, for 48 weeks.
Other Names:
  • Pegasys

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
week 24 from treatment start

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: week 12, 24, 48 from treatment start and week 24 after treatment
  • Average of HBV DNA decline level at week 12, 48 and 72.
  • Proportion of patients with HBV DNA undetectable at week 48 and 72.
  • Proportion of patients with HBeAg undetectable and HBeAg seroconversion at week 48 and 72.
  • Proportion of patients with HBsAg undetectable and HBsAg seroconversion at week 48 and 72.
  • Proportion of patients with ALT normalization at week 24 and 48.
week 12, 24, 48 from treatment start and week 24 after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiamen Amoytop Biotech Co., Ltd.

Collaborators

Peking University First Hospital

Investigators

  • Principal Investigator: Wang Guiqiang, MD, PhD, Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

June 11, 2010

First Submitted That Met QC Criteria

June 11, 2010

First Posted (ESTIMATE)

June 14, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 4, 2013

Last Update Submitted That Met QC Criteria

January 31, 2013

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TB1007IFN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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