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

November 1, 2016 updated by: Hoffmann-La Roche

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10969
      • Frankfurt Am Main, Germany, 60590
      • Hamburg, Germany, 20099
      • Hannover, Germany, 30625
      • Leipzig, Germany, 04103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A/B
Drug: peginterferon alfa 2a [Pegasys]
sc weekly
Drug: peginterferon alfa-2a [Pegasys]
iv weekly
Drug: peginterferon alfa-2a [Pegasys]
sc twice weekly
Drug: peginterferon alfa-2a [Pegasys]
iv twice weekly
Experimental: C/D
Drug: peginterferon alfa-2a [Pegasys]
iv weekly
Drug: peginterferon alfa-2a [Pegasys]
sc twice weekly
Drug: peginterferon alfa-2a [Pegasys]
iv twice weekly

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 11 months
11 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

March 29, 2011

First Submitted That Met QC Criteria

April 15, 2011

First Posted (Estimate)

April 18, 2011

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML22936

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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