A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus Ribavirin for Patients With Genotype 1 Hepatitis C and IL28B CC Polymorphism

September 28, 2013 updated by: Cai Qingxian, Third Affiliated Hospital, Sun Yat-Sen University
Patients with HCV genotype 1 and IL28B CC Polymorphism who have a rapid virological response to treatment are randomised to either 24 or 48 weeks HCV treatment. Our hypothesis is that there is no important difference in effect between the two treatment effect.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

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
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • The Eighth People's Hospital of Guangzhou
        • Contact:
        • Principal Investigator:
          • Xu Min, doctor
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • The Third Affliated Hospital of Sun Yat-sen University
        • Contact:
        • Principal Investigator:
          • Zhang Xiaohong, Doctor
        • Sub-Investigator:
          • Lin Chaoshuang, doctor
      • Guangzhou, Guangdong, China
        • Recruiting
        • Panyu People's Hospital
        • Contact:
          • Huang mingshou, Bachelor
          • Phone Number: +86013711033556
        • Principal Investigator:
          • Huang mingshou, Bachelor
      • Zhongshan, Guangdong, China
        • Recruiting
        • Zhongshan Second People's Hospital
        • Contact:
          • Wei min, Doctor
          • Phone Number: +86013702528182
        • Principal Investigator:
          • Wei min, doctor

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

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18 years
  • Serum Hepatitis C RNA > 10,000IU/mL
  • Hepatitis C virus genotype 1
  • IL28B CC polymorphism

Exclusion Criteria:

  • Previous treatment for chronic Hepatitis C
  • clinical or biological evidence of acute hepatitis, including serum ALT or AST > 300U/ml
  • HIV antibody positive, hepatitis b surface antigen positive or known diagnosis of other chronic liver disease

  • Contraindications to PR-based treatment:

    • Uncontrolled psychiatric illness
    • Active substance dependency
    • Known autoimmune disorder
    • Untreated thyroid disease
    • Uncontrolled seizure disorder
    • Pregnancy, lactation or inability to maintain contraception
    • Chronic kidney disease w/ estimated GFR< 60
    • ANC<1.5/nl, Hb<12g/dl, or platelets<75/nl

  • Clinical or biochemical evidence of decompensated liver disease including:

    • History of encephalopathy
    • Ascites
    • Variceal bleeding
    • Bilirubin > 3g/dl or INR > 1.5
    • Life threatening disorder with expected median survival less than 5 years
    • Inability to comply with drug regimens or testing schedule required for study

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 24-Week treatment group
Genotype 1 chronic hepatitis C patients with IL28B CC Polymorphism and rapid virological response(undetectable HCV RNA at weeks 4) in this group will be treated with Peginterferon alfa-2a plus ribavirin for an additional 20 weeks
Drug: Peginterferon alfa2a
patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks
Drug: Ribavirin
patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks
Drug: Peginterferon alfa2a
patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks
Drug: Ribavirin
patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks
Active Comparator: 48-Week treatment group
Genotype 1 chronic hepatitis C patients with IL28B CC Polymorphism and rapid virological response(undetectable HCV RNA at weeks 4) in this group will be treated with Peginterferon alfa-2a plus ribavirin for an additional 44 weeks
Drug: Peginterferon alfa2a
patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks
Drug: Ribavirin
patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks
Drug: Peginterferon alfa2a
patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks
Drug: Ribavirin
patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained virological response (SVR)
Time Frame: 24 weeks after the end of treatment
Undetectable HCVRNA in serum(<15IU/ml) 24 weeks after the end of treatment
24 weeks after the end of treatment

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Study Chair: Gao Zhiliang, Doctor, The Third Affliated Hospital of Sun Yat-sen University
  • Study Director: Zhao Zhixin, Doctor, The Third Affliated Hospital of Sun Yat-sen University
  • Principal Investigator: Zhang Xiaohong, Doctor, The Third Affliated Hospital of Sun Yat-sen University

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

May 1, 2011

Primary Completion (Anticipated)

May 1, 2014

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

September 24, 2011

First Submitted That Met QC Criteria

September 27, 2011

First Posted (Estimate)

September 28, 2011

Study Record Updates

Last Update Posted (Estimate)

October 1, 2013

Last Update Submitted That Met QC Criteria

September 28, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAHG1IL-28BCC

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.

Clinical Trials on Chronic Hepatitis C

Clinical Trials on Peginterferon alfa2a

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe