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

Tracking Information

First Received Date ^ICMJE

July 12, 2004

Last Updated Date

May 13, 2009

Start Date ^ICMJE

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Pharmacokinetic: Pegasys and PEG-Intron levels up to day 54

Change History

Complete list of historical versions of study NCT00087607 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Efficacy: Viral load reduction after 4, 8, and 12 weeks, weekly viral AUC and AAUCMB for duration of 12 treatment weeks
Safety: Vital signs, adverse events, and laboratory tests

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Pharmacodynamics Study

Condition ^ICMJE

Hepatitis C, Chronic

Intervention ^ICMJE

Drug: peginterferon alfa-2a (40KD) [PEGASYS]
Drug: Copegus
Drug: PEG-Intron
Drug: Rebetol

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

385

Completion Date

May 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Expanded Access Status

Administrative Information

NCT ID ^ICMJE

NCT00087607

Responsible Party

Clinical Trials, Study Director, Hoffmann-La Roche

Study ID Numbers ^ICMJE

ML17756

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

Information Provided By

Hoffmann-La Roche

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP