Efficacy and Safety Study of Peginterferon Alfa-2b in Chinese Chronic Hepatitis C Patients

October 6, 2014 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 Combination With Ribavirin in Chinese Chronic Hepatitis C Patients

The purpose of this study is to evaluate the efficacy and safety of Peginterferon alfa-2b (40KD, Y shape, the followings will refer as Ypeginterferon alfa-2b for short), at a dose of 180μg/week, in combination with Ribavirin in Chinese chronic hepatitis C patients. The study will first group patients into two sub-study, genotype 2/3 and non-genotype 2/3, depending on the HCV genotype that infected. In the genotype 2/3 sub-study about 219 patients will be enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group or active control group (Pegasys), receiving 24 weeks of interferon therapy and oral daily Ribavirin at a dose of 800mg/d. In the non-genotype 2/3 sub-study about 507 patients will be enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group or active control group (Pegasys), receiving 48 weeks of interferon therapy and oral daily Ribavirin 1000-1200mg/day , basing on body weight. All patients will be followed for 24 weeks after the end of therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

770

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
        • 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
      • Guangzhou, China
        • Third Affiliated Hospital of Sun Yat-sen University
      • Guilin, China
        • First Affiliated Hospital of Guangxi Medical University
      • Guiyang, China
        • Affiliated Hospital of Guiyang Medical College
      • 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
        • Renji Hospital
      • Shanghai, China
        • Shanghai Public Health Clinical Center
      • Shanghai, China
        • Huashan Hospital
      • Shanghai, China
        • 85 Militay Hospital
      • Shanghai, China
        • Ruijing Hospital
      • Shijiazhuang, China
        • Third Affiliated Hospital, Hebei Medical University
      • Taiyuan, China
        • First Affiliated Hospital, Shanxi University
      • Tianjin, China
        • Tianjin Third Central Hospital
      • Wuhan, China
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Wuhan, China
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Wulumuqi, China
        • First Affiliated Hospital of Xinjiang Medical University
      • Xiamen, China
        • The First Affiliated Hospital of Xiamen University
      • Xian, China
        • Xijing Hospital
      • Xian, China
        • Tangdu Hospital, Fourth Military Medical University
      • Zhengzhou, China
        • First Affiliated Hospital of Zhengzhou University
      • Zhengzhou, China
        • Hennan Provincial People's 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:

  • 18~65 years
  • Hepatitis virus C chronic infection evidences: HCV RNA or anti-HCV positive>6 months,or other evidences supporting diagnosis of chronic hepatitis C infection
  • HCV RNA≥2000IU/mL, anti-HCV positive at screening
  • Pregnancy tests for female patients must be negative. All patients must take effective contraception measures during the study period
  • Signed informed consent

Exclusion Criteria:

  • Pregnant or lactating women
  • Mental or psychology disorder
  • ANC<1500/mm3, or PLT<90,000/mm3, or Hb<ULN(Upper limit of Normal)
  • Received interferon treatment within the previous 6 months or shown no-response to previous interferon treatment
  • Co-infection with HIV, HAV, HBV, HEV
  • Evidence of hepatic decompensation (e.g: Child Plug≥B, prothrombin time prolonged more than 3 seconds, TBil>2ULN, Alb<35g/L)
  • Hepatocarcinoma or suffering from any other malignant tumor
  • Not well controlled endocrine diseases(e.g:thyroid disfunction, mellitus mellitus)
  • Significant function damage in any major organs (e.g: heart, lung, kidney)
  • Involved in other investigation within the previous 3 months
  • 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: A1(Genotype2/3)
Ypeginterferon alfa-2b 180μg/week, in combination with Ribavirin 800mg/day
Drug: Ypeginterferon alfa-2b
sc, qw, 24 weeks.
Drug: Ypeginterferon alfa-2b
sc, qw, 48 weeks.
ACTIVE_COMPARATOR: A2(Genotype 2/3)
Pegasys 180μg/week, in combination with Ribavirin 800mg/day
Drug: Pegasys
sc, qw, 24 weeks.
Drug: Pegasys
sc, qw, 48 weeks.
EXPERIMENTAL: B1(Non-genotype 2/3)
Ypeginterferon alfa-2b 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight
Drug: Ypeginterferon alfa-2b
sc, qw, 24 weeks.
Drug: Ypeginterferon alfa-2b
sc, qw, 48 weeks.
ACTIVE_COMPARATOR: B2(Non-genotype 2/3)
Pegasys 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight.
Drug: Pegasys
sc, qw, 24 weeks.
Drug: Pegasys
sc, qw, 48 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with sustained virologic response (defined as HCV RNA<15IU/ml at 24 weeks after the end of therapy)
Time Frame: 24 weeks after the end of therapy
24 weeks after the end of therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with HCV RNA undetectable (defined as HCV RNA <15IU/ml)
Time Frame: at weeks 4, 12, 24 for genotype 2/3, and weeks 4, 12, 24 and 48 for non-genotype 2/3
at weeks 4, 12, 24 for genotype 2/3, and weeks 4, 12, 24 and 48 for non-genotype 2/3

Collaborators and Investigators

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

Sponsor

Xiamen Amoytop Biotech Co., Ltd.

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

April 1, 2012

Primary Completion (ACTUAL)

April 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

February 16, 2012

First Submitted That Met QC Criteria

April 18, 2012

First Posted (ESTIMATE)

April 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 7, 2014

Last Update Submitted That Met QC Criteria

October 6, 2014

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TB1203IFN

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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