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

Chronic Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01263860
• Other study ID #: TAH115G6HCV
• Status: Completed
• Phase: Phase 3
• First received: December 20, 2010
• Last updated: November 14, 2014
• Start date: December 2010
• Est. completion date: June 2014

Study information

• Verified date: November 2014
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Peginterferon alfa2a
patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks
• Ribavirin
patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks
• Peginterferon alfa2a
patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks
• Ribavirin
patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks

Locations

Country	Name	City	State
China	Panyu People's Hospital	Guangzhou	Guangdong
China	The Eighth People's Hospital of Guangzhou	Guangzhou	Guangdong
China	The Third Affliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	Zhongshan second people's hospital	Zhongshan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virological response (SVR)	Undetectable HCVRNA in serum(<15IU/ml) 24 weeks after the end of treatment	24 weeks after the end of treatment	No
Secondary	Change in health related quality as measured by short from 36 (SF-36) from baseline to 24 weeks after the end of treatment		24 weeks after the end of treatment	No
Secondary	Sick leave in patients treated for 24 or 48 weeks treatment		48 weeks	Yes