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

August 28, 2015 updated by: Xiamen Amoytop Biotech Co., Ltd.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

820

Phase

  • Phase 3

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
        • Beijing Ditan Hospital Capital Medical University
      • 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
      • Chongqing, China
        • Second Affiliated Hospital Chongqing Medical University
      • Fuzhou, China
        • Fuzhou Infectious Disease Hospital
      • Guangzhou, China
        • Guangzhou Eighth People's Hospital
      • Guangzhou, China
        • Nanfang Hospital
      • 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
      • Jinan, China
        • Jinan Infectious Disease Hospital
      • Lanzhou, China
        • First Affiliated Hospital of Lanzhou University
      • Nanchang, China
        • First Affiliated Hospital of Nanchang University
      • Nanchang, China
        • 81 Military Hospital
      • Nanjing, China
        • Jiangsu Province Hospital
      • Nanjing, China
        • Second Hospital of Nanjing
      • Shanghai, China
        • Shanghai Public Health Clinical Center
      • Shanghai, China
        • Huashan Hospital
      • Shanghai, China
        • Ruijing Hospital
      • Shanghai, China
        • 85 Military Hospital
      • Shenyang, China
        • Shengjing Hospital of China Medical University
      • Shenyang, China
        • Shenyang Sixed 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
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • Wuhan, China
        • Tongji hospital, Huazhong University of Science & Technology
      • Wulumuqi, China
        • First Affiliated Hospital of Xinjiang Medical University
      • Xi'an, China
        • Tangdu Hospital, Fourth Military Medical University
      • Xi'an, China
        • Xijing Hospital
      • Xiamen, China
        • The First Affiliated Hospital of Xiamen University
      • Zhengzhou, China
        • Henan Provincial People's Hospital
    • Fujian
      • Xiamen, Fujian, China, 361000
        • Xiamen Hospital of T.C.M
    • Guangdong
      • Shenzhen, Guangdong, China, 518036
        • Beijing University Shenzhen Hospital

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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/mm3.
  • 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)
  • Significant function damage in any major organs (e.g.: heart, lung, kidney).
  • Other Conditions which in the opinion of the investigator precluding enrollment into the study (e.g.: poor compliance).

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: Ypeginterferon Alfa-2b
Drug: Ypeginterferon alfa-2b
sc, qw, 48 weeks.
Active Comparator: Pegasys
Drug: Pegasys
sc, qw, 48 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with HBeAg seroconversion at week72
Time Frame: 24 weeks after the cessation of treatment
24 weeks after the cessation of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of Patients with HBeAg seroconversion at week 12,24,48
Time Frame: week 12, 24, 48 from treatment starting
week 12, 24, 48 from treatment starting
Proportion fo patients with HBeAg undetectable at week 12, 24, 48, and 72.
Time Frame: week 4, 12, 24, 48 and 72 from treatment starting
week 4, 12, 24, 48 and 72 from treatment starting
Average of HBV DNA decline level at week 12, 24,48 and 72
Time Frame: week 12, 24, 48 and 72 from treatment starting
week 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.
Time Frame: week 12, 24, 48 and 72 from treatment starting
week 12, 24, 48 and 72 from treatment starting
Proportion of patients with ALT normalization at week 12,24, 48 and 72.
Time Frame: week 12, 24, 48 and 72 from treatment starting
week 12, 24, 48 and 72 from treatment starting

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, Ph.D, 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

March 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

December 30, 2012

First Submitted That Met QC Criteria

December 30, 2012

First Posted (Estimate)

January 3, 2013

Study Record Updates

Last Update Posted (Estimate)

August 31, 2015

Last Update Submitted That Met QC Criteria

August 28, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TB1211IFN

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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