NCT00641654

Combination Therapy With Pegylated Interferon and Ribavirin in Patients With Chronic Hepatitis C Genotype 2 or 3 Infection Who Previously Have Relapsed After Therapy With Pegylated Interferon and Ribavirin

An Open-label Multicenter Study Evaluating the Efficacy and Safety of 24 or 48 Weeks Pegylated Interferon Alfa-2a 40 kD (PEGASYS) Combination Therapy With Ribavirin (Copegus) in Patients With Chronic Hepatitis C Genotype 2 or 3 Infection Who Previously Have Relapsed After a Minimum of 12 Weeks and a Maximum of 24 Weeks of Therapy With Pegylated Interferon and Ribavirin

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Göteborg University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of pegylated interferon alfa-2a 40 kD (PEGASYS) combination therapy with ribavirin (Copegus)given for 24 or 48 weeks in patients with chronic hepatitis C (CHC) virus infection genotype 2 or 3 who responded during (i.e. had HCV-RNA \<50 IU/mL at the end of previous therapy), but relapsed after (i.e. had detectable HCV-RNA after the end of prior treatment) previous therapy with pegylated interferon and ribavirin given for at least 12 weeks and at most 24 weeks.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	Pegylated interferon alfa-2a and ribavirin	Arm A: Pegylated interferon alfa-2a Injection, 180 µg sc x 1/w for 48 weeks Ribavirin Tablet 200 mg weight based 5 or 6 per day for 48 weeks
DRUG	Pegylated interferon alfa-2a and ribavirin	Arm B:Pegylated interferon alfa-2a Injection, 180 µg sc x 1/w for 48 weeks Ribavirin Tablet 200 mg weight based 5 or 6 per day for 48 weeks
DRUG	Pegylated interferon alfa-2a and ribavirin	Arm C:Pegylated interferon alfa-2a Injection, 180 µg sc x 1/w for 24 weeks Ribavirin Tablet 200 mg weight based 5 or 6 per day for 24 weeks

Timeline

• Start date: 2007-01-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2008-03-24
• Last updated: 2012-08-30

Locations

1 site across 1 country: Sweden