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: August 4, 2014
Last verified: August 2014
  Purpose

In this randomized, cross-over, open label study the correlation of Pegasys (peg interferon alfa-2a) pharmacokinetics after intravenous (iv) and subcutaneous (sc

) administration with viral load and viral kinetics will be investigated in pati ents with chronic hepatitis C genotype 1 who were non-responders to previous sta ndard combination therapy with pegylated interferon and ribavirin. Patients will be randomized to receive either weekly or twice weekly Pegasys iv or sc for 2 w eeks, crossing over to the other mode of administration after a washout period o f 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:


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:
  • Evaluation of predictors of response to i.v. treatment [ Time Frame: 11 months ] [ Designated as safety issue: No ]
  • Effect of waist to hip ratio on pharmacokinetics [ Time Frame: 11 months ] [ Designated as safety issue: No ]
  • Effect of waist to hip ratio on viral response [ Time Frame: 11 months ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ 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]
iv weekly
Drug: peginterferon alfa 2a [Pegasys]
sc 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 4, 2014
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 August 18, 2014