A Study of Combination Treatment With Pegasys (Peginterferon Alfa) and Copegus (Ribavirin)in Patients With Chronic Hepatitis C

Hepatitis C, Chronic Clinical Trial

Official title:

Safety and Tolerability of Ribavirin (Ro 20-9963) in Combination With Peginterferon Alfa in Patients With Chronic Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00940420
• Other study ID #: ML16837
• Status: Completed
• Phase: Phase 4
• First received: July 6, 2009
• Last updated: November 1, 2016
• Start date: October 2002
• Est. completion date: November 2009

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This 2 arm open-label study will assess the safety and tolerability of combination treatment with Peginterferon alfa (Pegasys) and Ribavirin (Copegus) in patients with chronic hepatitis C. Patients will be assigned to receive Peginterferon alfa (Pegasys) 180 mcg sc once a week and Ribavirin (Copegus) 800 - 1200 mg po daily for either 24 or 48 weeks. Allocation to the treatment arms is to the discretion of the investigator (mainly according to genotype). Adverse events will be monitored throughout the study and hematologic parameters every 2 weeks and twice during the 24-week follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2695
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients >/= 18 years of age

• serologic evidence of chronic hepatitis C infection

• compensated liver disease

• negative pregnancy test and in both males and females use of 2 forms of contraception during study and 6 months after treatment

Exclusion Criteria:

• history or other evidence of a medical condition associated with chronic liver disease other than HCV

• hepatitis A, hepatitis B or HIV infection

• hepatocellular carcinoma

• severe concomitant disease

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Copegus (ribavirin)
800 - 1200 mg po daily for 24 weeks
• Copegus (ribavirin)
800 - 1200 mg po daily for 48 weeks
• peginterferon alfa-2a [Pegasys]
180 mcg sc once weekly for 24 weeks
• peginterferon alfa-2a [Pegasys]
180 mcg sc once weekly for 48 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety and tolerability with regard to clinical AEs and laboratory parameters		assessed every 2 weeks throughout study and after 8 weeks follow-up	No
Secondary	safety with regard to hematological parameters		assessed every 2 weeks throughout study and after 8 and 24 weeks of follow up	No