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

This study is currently recruiting participants.
Verified September 2013 by Third Affiliated Hospital, Sun Yat-Sen University
Sponsor:
Information provided by (Responsible Party):
Cai Qingxian, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01441804
First received: September 24, 2011
Last updated: September 28, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C
Drug: Peginterferon alfa2a
Drug: Ribavirin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Third Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • Sustained virological response (SVR) [ Time Frame: 24 weeks after the end of treatment ] [ Designated as safety issue: No ]
    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 from 36 (SF-36) from baseline to 24 weeks after the end of treatment [ Time Frame: baseline, 24 weeks after the end of treatment ] [ Designated as safety issue: No ]
  • Sick leave in patients treated for 24 or 48 weeks treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: May 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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 48 weeks
Drug: Ribavirin
patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441804

Contacts
Contact: Cai Qingxian, doctor +86013760857996 cqx200000@163.com
Contact: Zhao Zhixin, doctor +86013527873714 zxzhao@21cn.com

Locations
China, Guangdong
The Third Affliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Cai Qingxian, doctor    13760857996    Cqx200000@163.com   
Principal Investigator: Zhang Xiaohong, Doctor         
Sub-Investigator: Lin Chaoshuang, doctor         
The Eighth People's Hospital of Guangzhou Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Chen Fengjuan, Doctor    13416167557    fengjuandj@163.com   
Principal Investigator: Xu Min, doctor         
Panyu People's Hospital Recruiting
Guangzhou, Guangdong, China
Contact: Huang mingshou , Bachelor    +86013711033556      
Principal Investigator: Huang mingshou, Bachelor         
Zhongshan second people's hospital Recruiting
Zhongshan, Guangdong, China
Contact: Wei min, Doctor    +86013702528182      
Principal Investigator: Wei min, doctor         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Cai Qingxian, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01441804     History of Changes
Other Study ID Numbers: TAHG1IL-28BCC
Study First Received: September 24, 2011
Last Updated: September 28, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014