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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic

Intervention: Copegus (Drug); PEG-Intron (Drug); Rebetol (Drug); peginterferon alfa-2a [Pegasys] (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

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.

Clinical Details

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-na´ve Patients With Chronic Hepatitis C Viral Infection

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Viral load reduction from baseline.

Secondary outcome:

Viral load reduction

Viral AUC and AAUCMB.

AEs, laboratory parameters.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Birmingham, Alabama 35295-0005, United States

Little Rock, Arkansas 72205, United States

Sacramento, California 95817, United States

San Diego, California 92103, United States

San Diego, California 92123, United States

San Francisco, California 94143, United States

San Mateo, California 94403, United States

San Rafael, California 94901, United States

Farmington, Connecticut 06030, United States

Hartford, Connecticut 06015, United States

Bradenton, Florida 34209, United States

Miami, Florida 33125, United States

Wellington, Florida 33414, United States

Chicago, Illinois 60612, United States

Kansas City, Kansas 66160, United States

New Orleans, Louisiana 70115, United States

Baltimore, Maryland 21205, United States

Boston, Massachusetts 02215, United States

Burlington, Massachusetts 01805, United States

Detroit, Michigan 48201, United States

Kansas City, Missouri 64131, United States

St Louis, Missouri 63104, United States

Omaha, Nebraska 68198, United States

Las Vegas, Nevada 89128, United States

East Orange, New Jersey 07018, United States

Egg Harbour Township, New Jersey 08234, United States

Vineland, New Jersey 08360, United States

Bronx, New York 10467, United States

New York, New York 10016, United States

New York, New York 10021, United States

Poughkeepsie, New York 12601, United States

Fayetteville, North Carolina 28304, United States

Statesville, North Carolina 28677, United States

Portland, Oregon 97239, United States

Pittsburgh, Pennsylvania 15224, United States

Columbia, South Carolina 29204, United States

Austin, Texas 78758, United States

Dallas, Texas 75203, United States

Salt Lake City, Utah 84132, United States

Fairfax, Virginia 22031, United States

Norfolk, Virginia 23502, United States

Roanoke, Virginia 24016, United States

Tacoma, Washington 98405, United States

Racine, Wisconsin 53405, United States

Additional Information

Starting date: December 2003
Last updated: August 17, 2015

Page last updated: August 23, 2015

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