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Completed

NCT Number: NCT01433887

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

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.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Eighth People's Hospital of Guangzhou, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

48-weeks course

Drug

patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks

Ribavirin

Drug

patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks

Peginterferon alfa2a

Drug

patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Sick leave in patients treated for 24 or 48 weeks treatment

    Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study title

Response to Pegylated Interferon and Ribavirin in Chinese Patients With Chronic

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 14, 2011
Registry last updated
Nov 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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