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Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C (PEGIFN)

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Ypeginterferon alfa-2b
Peginterferon alfa-2a
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 HCV, CHC, Hepatitis C, Chronic, Liver Diseases, Hepatitis, Chronic, Hepatitis, Viral, Human, Hepadnaviridae Infections, Antiviral Agents, Virus Diseases, Peginterferon alfa

Eligibility Criteria

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

Inclusion Criteria:

  • Age: 18~65 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.
  • Chronic HCV infection evidence: HCV RNA or anti-HCV positive >6 months; liver biopsy evidence; vital signs, symptoms, exposure history, and results of laboratory test and iconography examination support diagnosis of chronic hepatitis C.
  • HCV RNA≥2000IU/ml.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Mental disorder or physical disability.
  • WBC<3000/mm3, or ANC <1500/mm3, or PLT <90,000/mm3.
  • Received interferon treatment within the previous 6 months or shew no response to interferon.
  • Co-infection with HIV, HAV, HBV, HEV.
  • Evidence of hepatic decompensation.
  • Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease.
  • History of hypothyroidism or current treatment for thyroid disease.
  • Diabetes mellitus.
  • Uncontrolled significant chronic medical conditions other than chronic hepatitis C or other conditions which in the opinion of the investigator preclude enrollment into the study.

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
  • Nangfang Hospital
  • First Affiliated Hospital of Guangxi Medical Universtiy
  • 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 Military Hospital
  • Changhai Hospital
  • Huashan Hospital
  • Renji Hospital
  • Ruijin Hospital
  • Shanghai Public Health Clinical Center
  • Shenzhen Third People's Hospital
  • Third Affiliated Hospital, Hebei Medical University
  • First Affiliated Hospital, Shanxi University
  • Tianjin Third Central Hospital
  • First Affiliated Hospital of Wenzhou Medical College
  • Tongji Hospital, Huazhong University of Science&Technology
  • Tangdu Hospital, Fouth Military Medical University
  • First Affiliated Hospital of Zhengzhou University
  • Henan Provincial People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

Ypeginterferon alfa-2b 90mcg per Week, with Ribavirin 1000-1200mg/d

Ypeginterferon alfa-2b 135mcg per Week, with Ribavirin 1000-1200mg/d

Ypeginterferon alfa-2b 180mcg per Week, with Ribavirin 1000-1200mg/d

Pegasys 180mcg per Week, with Ribavirin 1000-1200mg/d

Outcomes

Primary Outcome Measures

Efficacy
Proportion of patients with HCV RNA undetectable at week 12.

Secondary Outcome Measures

Efficacy
Proportion of patients with HCV RNA undetectable at Week 4, 24,48 and 72; Average decline level of log10 of HCV RNA at Week 4, 12, 24, 48 and 72.

Full Information

First Posted
June 8, 2010
Last Updated
January 31, 2013
Sponsor
Xiamen Amoytop Biotech Co., Ltd.
Collaborators
Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01140997
Brief Title
Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C
Acronym
PEGIFN
Official Title
A Multi-center, Randomized, Open-label and Positive Controlled Phase II Clinical Trial to Assess Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiamen Amoytop Biotech Co., Ltd.
Collaborators
Peking University People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a multi-center, randomized, open-label and positive controlled Phase II Clinical trial to assess the efficacy and safety of Ypeginterferon alfa-2b (with Ribavirin), once a week, in 3 dose-groups respectively, for treatment of Chronic Hepatitis C patients, with Pegasys 180mcg/week & Ribavirin 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 the PK data in hepatitis C patients to satisfy regulatory requirements.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
HCV, CHC, Hepatitis C, Chronic, Liver Diseases, Hepatitis, Chronic, Hepatitis, Viral, Human, Hepadnaviridae Infections, Antiviral Agents, Virus Diseases, Peginterferon alfa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Ypeginterferon alfa-2b 90mcg per Week, with Ribavirin 1000-1200mg/d
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Ypeginterferon alfa-2b 135mcg per Week, with Ribavirin 1000-1200mg/d
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Ypeginterferon alfa-2b 180mcg per Week, with Ribavirin 1000-1200mg/d
Arm Title
Group 4
Arm Type
Active Comparator
Arm Description
Pegasys 180mcg per Week, with Ribavirin 1000-1200mg/d
Intervention Type
Drug
Intervention Name(s)
Ypeginterferon alfa-2b
Other Intervention Name(s)
Peginterferon alfa-2b
Intervention Description
sc, qw, for 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a
Other Intervention Name(s)
Pegasys
Intervention Description
sc, qw, for 48 weeks.
Primary Outcome Measure Information:
Title
Efficacy
Description
Proportion of patients with HCV RNA undetectable at week 12.
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Efficacy
Description
Proportion of patients with HCV RNA undetectable at Week 4, 24,48 and 72; Average decline level of log10 of HCV RNA at Week 4, 12, 24, 48 and 72.
Time Frame
Week 4, 12, 24, 48 and 72

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: Age: 18~65 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. Chronic HCV infection evidence: HCV RNA or anti-HCV positive >6 months; liver biopsy evidence; vital signs, symptoms, exposure history, and results of laboratory test and iconography examination support diagnosis of chronic hepatitis C. HCV RNA≥2000IU/ml. Exclusion Criteria: Pregnant or lactating women. Mental disorder or physical disability. WBC<3000/mm3, or ANC <1500/mm3, or PLT <90,000/mm3. Received interferon treatment within the previous 6 months or shew no response to interferon. Co-infection with HIV, HAV, HBV, HEV. Evidence of hepatic decompensation. Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease. History of hypothyroidism or current treatment for thyroid disease. Diabetes mellitus. Uncontrolled significant chronic medical conditions other than chronic hepatitis C or other conditions which in the opinion of the investigator preclude enrollment into the study.
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
Nangfang Hospital
City
Guangzhou
Country
China
Facility Name
First Affiliated Hospital of Guangxi Medical Universtiy
City
Guilin
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 Military Hospital
City
Shanghai
Country
China
Facility Name
Changhai Hospital
City
Shanghai
Country
China
Facility Name
Huashan Hospital
City
Shanghai
Country
China
Facility Name
Renji Hospital
City
Shanghai
Country
China
Facility Name
Ruijin Hospital
City
Shanghai
Country
China
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
Country
China
Facility Name
Shenzhen Third People's Hospital
City
Shenzhen
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
First Affiliated Hospital of Wenzhou Medical College
City
Wenzhou
Country
China
Facility Name
Tongji Hospital, Huazhong University of Science&Technology
City
Wuhan
Country
China
Facility Name
Tangdu Hospital, Fouth Military Medical University
City
Xian
Country
China
Facility Name
First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
Country
China
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
24625322
Citation
Feng B, Yang RF, Xie Q, Shang J, Kong FY, Zhang HY, Rao HY, Jin Q, Cong X, Liu YY, Kang Y, Wei L. Hepatitis C virus core antigen, an earlier and stronger predictor on sustained virological response in patients with genotype 1 HCV infection. BMC Gastroenterol. 2014 Mar 13;14:47. doi: 10.1186/1471-230X-14-47.
Results Reference
derived

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Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C

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