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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01433887
First Posted: September 14, 2011
Last Update Posted: November 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cai Qingxian, Third Affiliated Hospital, Sun Yat-Sen University
  Purpose
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.

Condition Intervention Phase
Chronic Hepatitis C Drug: 48-weeks course Drug: Ribavirin Drug: Peginterferon alfa2a Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Response to Pegylated Interferon and Ribavirin in Chinese Patients With Chronic

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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


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 [ Time Frame: 24 weeks after the end of treatment ]
  • Sick leave in patients treated for 24 or 48 weeks treatment [ Time Frame: 48 weeks ]

Enrollment: 535
Study Start Date: November 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Genotype 6
Genotype 6 chronic hepatitis C patients will be treated with Peginterferon alfa-2a plus ribavirin for 48 weeks
Drug: 48-weeks course
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: Genotype 1
Genotype 1 chronic hepatitis C patients will be treated with Peginterferon alfa-2a plus ribavirin for 48 weeks
Drug: 48-weeks course
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: Genotype 2/3
Genotype 2/3 chronic hepatitis C patients will be treated with Peginterferon alfa-2a/2b plus ribavirin for 24 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

  Eligibility

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01433887


Locations
China, Guangdong
The Eighth People's Hospital of Guangzhou
Guangzhou, Guangdong, China, 510000
The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
Zhongshan second people's hospital
Zhongshan, Guangdong, China
Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
  More Information

Responsible Party: Cai Qingxian, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01433887     History of Changes
Other Study ID Numbers: TAH5010G6HCV
First Submitted: September 11, 2011
First Posted: September 14, 2011
Last Update Posted: November 18, 2014
Last Verified: November 2014

Keywords provided by Cai Qingxian, Third Affiliated Hospital, Sun Yat-Sen University:
Peginterferon alfa-2a
ribavirin

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