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NCT Number: NCT01263860

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

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.

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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

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Panyu People's Hospital, Guangzhou, Guangdong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Peginterferon alfa2a

Drug

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

Ribavirin

Drug

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

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 21, 2010
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.

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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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