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

Chronic Hepatitis C Clinical Trial

Official title:

Response to Pegylated Interferon and Ribavirin in Chinese Patients With Chronic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01433887
• Other study ID #: TAH5010G6HCV
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2011
• Last updated: November 14, 2014
• Start date: November 2011
• 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 535
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• 48-weeks course
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
• 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

Locations

Country	Name	City	State
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 form 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