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

Roche

Status and phase

Completed

Phase 1

Conditions

Hepatitis C, Chronic

Treatments

Drug: peginterferon alfa-2a [Pegasys]

Drug: peginterferon alfa 2a [Pegasys]

Study type

Interventional

Funder types

Industry

Identifiers

NCT01337375

ML22936

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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