PEAK Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC).

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00087607
First received: July 12, 2004
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

This study will examine the viral kinetics and pharmacokinetics of PEGASYS plus ribavirin and PEG-Intron plus ribavirin in interferon-naive patients with CHC. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: peginterferon alfa-2a [Pegasys]
Drug: Copegus
Drug: PEG-Intron
Drug: Rebetol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label Study to Compare the Effect of PEGASYS Plus Ribavirin and PEG-Intron Plus Ribavirin on Viral Load Reduction in Interferon-naïve Patients With Chronic Hepatitis C Viral Infection

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Viral load reduction from baseline. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Viral load reduction [ Time Frame: Weeks 4 and 8 ] [ Designated as safety issue: No ]
  • Viral AUC and AAUCMB. [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 385
Study Start Date: December 2003
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly
Drug: Copegus
1000/1200mg/day po
Active Comparator: 2 Drug: PEG-Intron
1.5 micrograms/kg sc weekly
Drug: Rebetol
1000/1200mg/day po

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients at least 18 years of age
  • CHC infection, genotype 1
  • use of 2 forms of contraception during study in both men and women

Exclusion Criteria:

  • previous systemic therapy with anti-viral, anti-neoplastic, or immunomodulatory agents
  • medical condition associated with chronic liver disease (eg, hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposure)
  • decompensated liver disease
  • women who are pregnant or breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087607

  Show 44 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00087607     History of Changes
Other Study ID Numbers: ML17756
Study First Received: July 12, 2004
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

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
Peginterferon alfa-2b
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 April 16, 2014