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A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus Ribavirin for HCV Genotype-6 Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cai Qingxian, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01263860
First received: December 20, 2010
Last updated: November 14, 2014
Last verified: November 2014

December 20, 2010
November 14, 2014
December 2010
June 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01263860 on ClinicalTrials.gov Archive Site
  • 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: 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 ]
Same as current
Not Provided
Not Provided
 
A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus Ribavirin for HCV Genotype-6 Patients
A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus

Patients with HCV genotype 6 infection 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.

High rate of infection of Hepatitis C Virus(HCV) Genotype 6 was recently confirmed in Southern China. Recent study implied chronic hepatitis C genotype 6 responds better to the 48-week treatment with pegylated interferon and ribavirin than genotype 1. Approximately 75.7% obtain sustained virological response (HCV RNA undetectable 24 weeks after treatment) to this approach. However, the treatment is associated with many and sometimes serious side effects. In addition, the treatment is costly also in economical terms. Shorter treatment for chronic hepatitis C genotype 6 is necessary to be assessed.

In this randomised,open label,multicenter phase 3 trial with active controls patients are treated with pegylated interferon alfa 2a (180ug/week)and ribavirin(800-1200mg based on weight)for 4 weeks. Those who are HCV RNA negative at week 4 (<50 IU; Cobas Amplicor Monitor Test, Roche Diagnostic) are defined as rapid virological responders and randomised to either an additional 20 or 44 weeks combination treatment. Patients who are HCV RNA positive are all treated for 44 more weeks. The endpoint is sustained virological response defined as undetectable HCV RNA 24 weeks after end of treatment.

Our hypothesis is that there is no important difference in the effect in the two groups.

This is a non-inferiority trial. The smallest difference considered to be clinically important is 15%. Thus to state "non-inferiority" the 95% confidence interval of the observed difference between the groups shall not overlap 10%. Both intention to treat and and per protocol analyses will be published. Conclusion will be conservative and based on the analysis who detect the biggest difference.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis C
  • 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
  • Experimental: 24-Week treatment group
    Genotype 6 chronic hepatitis C patients with 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
    Interventions:
    • Drug: Peginterferon alfa2a
    • Drug: Ribavirin
  • Active Comparator: 48-Week treatment group
    Genotype 6 chronic hepatitis C patients with 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
    Interventions:
    • Drug: Peginterferon alfa2a
    • Drug: Ribavirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
242
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HCV RNA is positive
  • Genotype 6
  • Treatment naive
  • Raised ALT

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01263860
TAH115G6HCV
No
Cai Qingxian, Third Affiliated Hospital, Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University
Not Provided
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
Principal Investigator: Xu Min, Doctor The Eighth People's Hospital of Guangzhou
Principal Investigator: Wei min, Doctor Zhongshan second people's hospital
Principal Investigator: Huang mingshou, Bachelor Panyu People's Hospital
Third Affiliated Hospital, Sun Yat-Sen University
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP