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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00087607

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 (40KD) [PEGASYS] Drug: Copegus Drug: PEG-Intron Drug: Rebetol	Phase IV

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a Interferon alfa-2b Peginterferon Alfa-2b Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Pharmacodynamics Study
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

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 Completion Date:	April 2006

Arms	Assigned Interventions
1: Experimental	Drug: peginterferon alfa-2a (40KD) [PEGASYS] 180 micrograms sc weekly Drug: Copegus 1000/1200mg/day po
2: Active Comparator	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, +1 973 235 5000

More Information

Publications indexed to this study:

Di Bisceglie AM, Ghalib RH, Hamzeh FM, Rustgi VK. Early virologic response after peginterferon alpha-2a plus ribavirin or peginterferon alpha-2b plus ribavirin treatment in patients with chronic hepatitis C. J Viral Hepat. 2007 Oct;14(10):721-9.

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML17756
Study First Received:	July 12, 2004
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00087607
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Ribavirin
Interferons
Hepatitis, Viral, Human
Hepatitis
Virus Diseases

Digestive System Diseases
Peginterferon alfa-2b
Peginterferon alfa-2a
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic
Interferon Alfa-2b

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances

Physiological Effects of Drugs
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009