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

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Ypeginterferon alfa-2b
Pegasys
Ypeginterferon alfa-2b
Pegasys
Sponsored by
Xiamen Amoytop Biotech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Peginterferon, Pegasys, Sustained virus response, HCV

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • 302 Military Hospital
  • Beijing Youan Hospital, Capital Medical University
  • Beijing Youyi Hospital, capital Medical University
  • Peking University First Hospital
  • Peking University People's Hospital
  • First Affiliated Hospital of Jilin University
  • Xiangya Hospital, Central-south University
  • Xiangya Second Hospital, Central-south University
  • West China Hospital, Sichuan University
  • Second Affiliated Hospital Chongqing Medical University
  • Southwest Hospital
  • Fuzhou Infectious Disease Hospital
  • Guangzhou Eighth People's Hospital
  • Nanfang Hospital
  • Third Affiliated Hospital of Sun Yat-sen University
  • First Affiliated Hospital of Guangxi Medical University
  • Affiliated Hospital of Guiyang Medical College
  • First Affiliated Hospital, Zhejiang University
  • Second Affiliated Hospital of Harbin Medical University
  • First Affiliated Hospital of Anhui Medical University
  • Jinan Infectious Disease Hospital
  • First Affiliated Hospital of Lanzhou University
  • First Affiliated Hospital of Nanchang University
  • 81 Military Hospital
  • Jiangsu Province Hospital
  • Second Hospital of Nanjing
  • 85 Militay Hospital
  • Huashan Hospital
  • Renji Hospital
  • Ruijing Hospital
  • Shanghai Public Health Clinical Center
  • Third Affiliated Hospital, Hebei Medical University
  • First Affiliated Hospital, Shanxi University
  • Tianjin Third Central Hospital
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • First Affiliated Hospital of Xinjiang Medical University
  • The First Affiliated Hospital of Xiamen University
  • Tangdu Hospital, Fourth Military Medical University
  • Xijing Hospital
  • First Affiliated Hospital of Zhengzhou University
  • Hennan Provincial People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

A1(Genotype2/3)

A2(Genotype 2/3)

B1(Non-genotype 2/3)

B2(Non-genotype 2/3)

Arm Description

Ypeginterferon alfa-2b 180μg/week, in combination with Ribavirin 800mg/day

Pegasys 180μg/week, in combination with Ribavirin 800mg/day

Ypeginterferon alfa-2b 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight

Pegasys 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of patients with HCV RNA undetectable (defined as HCV RNA <15IU/ml)

Full Information

First Posted
February 16, 2012
Last Updated
October 6, 2014
Sponsor
Xiamen Amoytop Biotech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01581398
Brief Title
Efficacy and Safety Study of Peginterferon Alfa-2b in Chinese Chronic Hepatitis C Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiamen Amoytop Biotech Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
Peginterferon, Pegasys, Sustained virus response, HCV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
770 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A1(Genotype2/3)
Arm Type
Experimental
Arm Description
Ypeginterferon alfa-2b 180μg/week, in combination with Ribavirin 800mg/day
Arm Title
A2(Genotype 2/3)
Arm Type
Active Comparator
Arm Description
Pegasys 180μg/week, in combination with Ribavirin 800mg/day
Arm Title
B1(Non-genotype 2/3)
Arm Type
Experimental
Arm Description
Ypeginterferon alfa-2b 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight
Arm Title
B2(Non-genotype 2/3)
Arm Type
Active Comparator
Arm Description
Pegasys 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight.
Intervention Type
Drug
Intervention Name(s)
Ypeginterferon alfa-2b
Intervention Description
sc, qw, 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Pegasys
Intervention Description
sc, qw, 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Ypeginterferon alfa-2b
Intervention Description
sc, qw, 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Pegasys
Intervention Description
sc, qw, 48 weeks.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Lai, MD, PhD
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
302 Military Hospital
City
Beijing
Country
China
Facility Name
Beijing Youan Hospital, Capital Medical University
City
Beijing
Country
China
Facility Name
Beijing Youyi Hospital, capital Medical University
City
Beijing
Country
China
Facility Name
Peking University First Hospital
City
Beijing
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
Country
China
Facility Name
First Affiliated Hospital of Jilin University
City
Changchun
Country
China
Facility Name
Xiangya Hospital, Central-south University
City
Changsha
Country
China
Facility Name
Xiangya Second Hospital, Central-south University
City
Changsha
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
Country
China
Facility Name
Second Affiliated Hospital Chongqing Medical University
City
Chongqing
Country
China
Facility Name
Southwest Hospital
City
Chongqing
Country
China
Facility Name
Fuzhou Infectious Disease Hospital
City
Fuzhou
Country
China
Facility Name
Guangzhou Eighth People's Hospital
City
Guangzhou
Country
China
Facility Name
Nanfang Hospital
City
Guangzhou
Country
China
Facility Name
Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
Country
China
Facility Name
First Affiliated Hospital of Guangxi Medical University
City
Guilin
Country
China
Facility Name
Affiliated Hospital of Guiyang Medical College
City
Guiyang
Country
China
Facility Name
First Affiliated Hospital, Zhejiang University
City
Hangzhou
Country
China
Facility Name
Second Affiliated Hospital of Harbin Medical University
City
Harbin
Country
China
Facility Name
First Affiliated Hospital of Anhui Medical University
City
Hefei
Country
China
Facility Name
Jinan Infectious Disease Hospital
City
Jinan
Country
China
Facility Name
First Affiliated Hospital of Lanzhou University
City
Lanzhou
Country
China
Facility Name
First Affiliated Hospital of Nanchang University
City
Nanchang
Country
China
Facility Name
81 Military Hospital
City
Nanjing
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
Country
China
Facility Name
Second Hospital of Nanjing
City
Nanjing
Country
China
Facility Name
85 Militay Hospital
City
Shanghai
Country
China
Facility Name
Huashan Hospital
City
Shanghai
Country
China
Facility Name
Renji Hospital
City
Shanghai
Country
China
Facility Name
Ruijing Hospital
City
Shanghai
Country
China
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
Country
China
Facility Name
Third Affiliated Hospital, Hebei Medical University
City
Shijiazhuang
Country
China
Facility Name
First Affiliated Hospital, Shanxi University
City
Taiyuan
Country
China
Facility Name
Tianjin Third Central Hospital
City
Tianjin
Country
China
Facility Name
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
Country
China
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
Country
China
Facility Name
First Affiliated Hospital of Xinjiang Medical University
City
Wulumuqi
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
Country
China
Facility Name
Tangdu Hospital, Fourth Military Medical University
City
Xian
Country
China
Facility Name
Xijing Hospital
City
Xian
Country
China
Facility Name
First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
Country
China
Facility Name
Hennan Provincial People's Hospital
City
Zhengzhou
Country
China

12. IPD Sharing Statement

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

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