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

Pharmacokinetics and Pharmacodynamics of Intravenous Administration of Pegylated Interferon-2a in Patients With Chronic Hepatitis C and Previous Non-response to Standard Combination Therapy With Pegylated Interferon and Ribavirin (Intervention Study)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01337375

Enrollment

Registered

2011-04-18

Start date

2011-03-31

Completion date

2012-04-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic

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.

Interventions

DRUGpeginterferon alfa 2a [Pegasys]

sc weekly

DRUGpeginterferon alfa-2a [Pegasys]

iv weekly

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026