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

Phase 1

Completed

• Conditions: Hepatitis C, Chronic
• Interventions: Drug: peginterferon alfa-2a [Pegasys]; Drug: peginterferon alfa 2a [Pegasys]

• Registration Number: NCT01337375
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-29
• Study First Submitted QC: 2011-04-15
• Study First Posted: 2011-04-18
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
C/D	peginterferon alfa-2a [Pegasys]	-
A/B	peginterferon alfa 2a [Pegasys]	-
A/B	peginterferon alfa-2a [Pegasys]	-

Primary Outcome Measures

Name	Time	Method
HCV RNA levels (IU/ml, COBAS TaqMan HCV Test) in correlation with area under the plasma concentration-time curve (AUC) after sc and iv administration	11 months

Secondary Outcome Measures

Name	Time	Method
Effect of waist to hip ratio on viral response	11 months
Effect of waist to hip ratio on pharmacokinetics	11 months
Evaluation of predictors of response to i.v. treatment	11 months
Incidence of adverse events	11 months