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Response to Pegylated Interferon and Ribavirin in Chinese Patients With Chronic Hepatitis C Genotypes 1 Versus 2/3 Versus 6

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
48-weeks course
Ribavirin
Peginterferon alfa2a
Ribavirin
Sponsored by
Third Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Peginterferon alfa-2a, ribavirin

Eligibility Criteria

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

Inclusion Criteria:

  • HCV RNA is positive
  • Treatment naive
  • Come from China

Exclusion Criteria:

  • Active substance abuse
  • Poorly controlled psychiatric disease
  • HBsAg positive
  • Anti-HIV positive
  • Suffering from other significant concurrent medical conditions including chronic liver diseases

Sites / Locations

  • The Eighth People's Hospital of Guangzhou
  • The Third Affliated Hospital of Sun Yat-sen University
  • Zhongshan second people's hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Genotype 6

Genotype 1

Genotype 2/3

Arm Description

Genotype 6 chronic hepatitis C patients will be treated with Peginterferon alfa-2a plus ribavirin for 48 weeks

Genotype 1 chronic hepatitis C patients will be treated with Peginterferon alfa-2a plus ribavirin for 48 weeks

Genotype 2/3 chronic hepatitis C patients will be treated with Peginterferon alfa-2a/2b plus ribavirin for 24 weeks

Outcomes

Primary Outcome Measures

Sustained virological response (SVR)
Undetectable HCVRNA in serum(<15IU/ml) 24 weeks after the end of treatment

Secondary Outcome Measures

Change in health related quality as measured by short form 36 (SF-36) from baseline to 24 weeks after the end of treatment
Sick leave in patients treated for 24 or 48 weeks treatment

Full Information

First Posted
September 11, 2011
Last Updated
November 14, 2014
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01433887
Brief Title
Response to Pegylated Interferon and Ribavirin in Chinese Patients With Chronic Hepatitis C Genotypes 1 Versus 2/3 Versus 6
Official Title
Response to Pegylated Interferon and Ribavirin in Chinese Patients With Chronic
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The Chinese patients with chronic hepatitis C have a different genetic background, which had been demonstrated to significantly influence their responses to pegylated interferon and ribavirin. In this study, Chinese patients with Hepatitis C Virus genotype 1, 2/3, 6 infection were treated with pegylated interferon and ribavirin. Their response was compared amongst different genotypes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
Peginterferon alfa-2a, ribavirin

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Genotype 6
Arm Type
Experimental
Arm Description
Genotype 6 chronic hepatitis C patients will be treated with Peginterferon alfa-2a plus ribavirin for 48 weeks
Arm Title
Genotype 1
Arm Type
Experimental
Arm Description
Genotype 1 chronic hepatitis C patients will be treated with Peginterferon alfa-2a plus ribavirin for 48 weeks
Arm Title
Genotype 2/3
Arm Type
Experimental
Arm Description
Genotype 2/3 chronic hepatitis C patients will be treated with Peginterferon alfa-2a/2b plus ribavirin for 24 weeks
Intervention Type
Drug
Intervention Name(s)
48-weeks course
Intervention Description
patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa2a
Intervention Description
patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks
Primary Outcome Measure Information:
Title
Sustained virological response (SVR)
Description
Undetectable HCVRNA in serum(<15IU/ml) 24 weeks after the end of treatment
Time Frame
24 weeks after the end of treatment
Secondary Outcome Measure Information:
Title
Change in health related quality as measured by short form 36 (SF-36) from baseline to 24 weeks after the end of treatment
Time Frame
24 weeks after the end of treatment
Title
Sick leave in patients treated for 24 or 48 weeks treatment
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HCV RNA is positive Treatment naive Come from China Exclusion Criteria: Active substance abuse Poorly controlled psychiatric disease HBsAg positive Anti-HIV positive Suffering from other significant concurrent medical conditions including chronic liver diseases
Facility Information:
Facility Name
The Eighth People's Hospital of Guangzhou
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
The Third Affliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Facility Name
Zhongshan second people's hospital
City
Zhongshan
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

Learn more about this trial

Response to Pegylated Interferon and Ribavirin in Chinese Patients With Chronic Hepatitis C Genotypes 1 Versus 2/3 Versus 6

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