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

This study is ongoing, but not recruiting participants.
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: June 6, 2013
Last verified: June 2013
  Purpose

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.


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
Official Title: A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus

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: 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 ]

Enrollment: 242
Study Start Date: December 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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 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
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01263860

Locations
China, Guangdong
The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
The Eighth People's Hospital of Guangzhou
Guangzhou, Guangdong, China, 510060
Panyu People's Hospital
Guangzhou, Guangdong, China
Zhongshan second people's hospital
Zhongshan, Guangdong, China
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
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
  More Information

No publications provided

Responsible Party: Cai Qingxian, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01263860     History of Changes
Other Study ID Numbers: TAH115G6HCV
Study First Received: December 20, 2010
Last Updated: June 6, 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 16, 2014