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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Ribavirin in Patients With Chronic Hepatitis C (CHC) Previously Treated With PEG-Intron + Ribavirin

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: Ribavirin (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 evaluate the efficacy, safety and tolerability of PEGASYS plus ribavirin in patients with CHC who could not tolerate or were not responsive to 12 weeks of therapy with PEG-Intron plus ribavirin. The anticipated time on study treatment is 1-2 years, and the target sample size is >100 individuals.

Clinical Details

Official title: An Open-label Study of the Safety and Tolerability of PEGASYS Plus Ribavirin in Patients With Chronic Hepatitis C Viral Infection Who Could Not Tolerate or Were Unresponsive to PEG-Intron Plus Ribavirin

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Proportion of patients able to complete prescribed length of Pegasys plus ribavirin therapy\n

Secondary outcome: Sum score of Beck Depression Inventory and Fatigue Severity Score, proportion of patients with each flu-like symptom, >=2 log drop or undetectable HCV-RNA, or normal ALT levels, adverse events, laboratory values\n

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

- unable to tolerate or not responsive to PEG-Intron + ribavirin therapy after 12 weeks

of treatment

- use of 2 forms of contraception during the study in both men and women

Exclusion Criteria:

- women who are pregnant or breast-feeding

- medical condition associated with chronic liver disease (eg, hemochromatosis,

autoimmune hepatitis, alcoholic liver disease, toxin exposures)

- patients with decompensated cirrhosis

- patients receiving any systemic antiviral therapy or investigational drug, other than

PEG-Intron + ribavirin, 24 weeks prior to the first dose of study drug

Locations and Contacts

Bakersfield, California 93301, United States

Pasadena, California 91105, United States

San Diego, California 92123, United States

San Mateo, California 94403, United States

Bradenton, Florida 34209, United States

Miami, Florida 33136-1051, United States

Orlando, Florida 32806, United States

Austell, Georgia 30106, United States

Annapolis, Maryland 21401, United States

Baltimore, Maryland 21229, United States

Boston, Massachusetts 02114, United States

Kansas City, Missouri 64131, United States

Bayside, New York 11358, United States

Brooklyn, New York 11219, United States

Manhasset, New York 11030, United States

New York, New York 10032, United States

Valhalla, New York 10595, United States

Statesville, North Carolina 28677, United States

Cincinnati, Ohio 45219, United States

Knoxville, Tennessee 37920, United States

Memphis, Tennessee 38120, United States

Houston, Texas 77054, United States

Fairfax, Virginia 22031, United States

Richmond, Virginia 23298, United States

Tacoma, Washington 98405, United States

Additional Information

Starting date: December 2002
Last updated: August 17, 2015

Page last updated: August 23, 2015

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