A Study of the Pharmacokinetics And Pharmacodynamics of Intravenously Administered Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C And Previous Non-Response to Pegylated Interferon And Ribavirin Combination Therapy

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

In this randomized, cross-over, open label study the correlation of Pegasys (peginterferon alfa-2a) pharmacokinetics after intravenous (iv) and subcutaneous (sc) administration with viral load and viral kinetics will be investigated in patients with chronic hepatitis C genotype 1 who were non-responders to previous standard combination therapy with pegylated interferon and ribavirin. Patients will be randomized to receive either weekly or twice weekly Pegasys iv or sc for 2 weeks, crossing over to the other mode of administration after a washout period of 6 weeks.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• Adult caucasian patients, 18 - 70 years of age

• Hepatitis C, genotype 1

• Non-responder to previous anti-HCV therapy with peginterferon alfa and ribavirin

• Compensated liver disease (Child-Pugh class A) for >/= 24 months before baseline

• Positive for anti-HCV for > 6 months, with detectable serum HCV-RNA

Exclusion Criteria:

• Treatment-naïve or responder to previous therapy

• HCV infection other than genotype 1

• Positive for Hepatitis A, Hepatitis B or HIV infection at screening

• Chronic Hepatitis of other than HCV origin

• Decompensated liver disease (Child-Pugh class B or C)

• Therapy with systemic antiviral, antineoplastic or immunomodulatory agents in the 6 months prior to study

• Clinically relevant retina disorder

• Pregnant or lactating women and male partners of pregnant women