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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01337375
First received: March 29, 2011
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Hepatitis C, Chronic
 Drug: peginterferon alfa 2a [Pegasys]
Drug: peginterferon alfa-2a [Pegasys]
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HCV RNA levels (IU/ml) in correlation with Interleukin 28B polymorphisms [ Time Frame: 11 months ] [ Designated as safety issue: No ]
  • HCV RNA levels (IU/ml) in correlation with interferon-stimulated genes [ Time Frame: 11 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 11 months ] [ Designated as safety issue: No ]
  • Blood levels (U/L) of gamma glutamyl transferase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST) [ Time Frame: 11 months ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: March 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A/B Drug: peginterferon alfa 2a [Pegasys]
sc weekly
Drug: peginterferon alfa-2a [Pegasys]
iv weekly
Experimental: C/D Drug: peginterferon alfa-2a [Pegasys]
sc twice weekly
Drug: peginterferon alfa-2a [Pegasys]
iv twice weekly

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337375

Locations
Germany
Berlin, Germany, 10969
Frankfurt Am Main, Germany, 60590
Hamburg, Germany, 20099
Hannover, Germany, 30625
Leipzig, Germany, 04103
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01337375     History of Changes
Other Study ID Numbers: ML22936
Study First Received: March 29, 2011
Last Updated: June 3, 2013
Health Authority: Germany: Bundesinstitut fur Arzneimittel und Medizinprodukte

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
 Interferons
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013