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A Study of Pegasys (Peginterferon Alfa-2a) Administered Alone or in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C Who Have Participated in Previous Pegasys Trials

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: Peginterferon alfa-2a (Drug); Ribavirin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Hoffmann-La Roche

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

Summary

This open-label, non-randomized, single arm study will provide treatment or re-treatment with Pegasys (peginterferon alfa-2a) as monotherapy or in combination with Copegus (ribavirin) to patients with chronic hepatitis C infection. Patients who have received prior Pegasys monotherapy or combination therapy or who were considered eligible for treatment with Pegasys in previous donor protocols will be eligible to participate in this study. Treatment will be on investigator's decision according to the approved label for up to 48 weeks, with a 24-week safety follow-up.

Clinical Details

Official title: An Open-label, Multicenter Protocol Providing Pegylated Interferon Alfa-2a (Pegasys®) as Monotherapy or in Combination With Ribavirin (Copegus®) for Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols

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

Primary outcome: Percentage of Participants With at Least 1 Adverse Event

Eligibility

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

Criteria:

Inclusion Criteria:

- Adult patients, ≥ 18 years of age.

- Chronic hepatitis C.

- Compensated liver disease (Child-Pugh Class A).

- Previous participation in a donor protocol in which treatment or re-treatment with

Pegasys alone or in combination with Copegus was recommended or deemed appropriate after study completion.

- Have completed safety and efficacy assessments as defined in the donor protocol

without violation or any major deviation.

- Have not received any other anti-hepatitis C virus treatment after the completion of

the donor protocol.

- For females of childbearing potential, a negative pregnancy test within 24 hours

prior to first dose of study drug.

- Fertile patients (male and female) must use 2 reliable forms of contraception

(combined) for the duration of the study (treatment and follow-up) in accordance with the locally approved label for Copegus. Exclusion Criteria:

- Pregnant or breastfeeding women.

- Male partners of women who are pregnant.

- Patients with hemoglobinopathies.

- Hepatic decompensation (Child-Pugh Class B or C) before or during treatment.

- Non-responder patients (defined as patients previously treated with Pegasys and

Copegus combination therapy at standard doses for at least 12 weeks who did not achieve at least a 2-log drop from their baseline viral load).

- Liver disease other than chronic hepatitis C, including hepatic carcinoma.

Locations and Contacts

Adelaide 5000, Australia

Herston 4006, Australia

Ribeirao Preto 14049-900, Brazil

Salvador 40150-130, Brazil

Sao Paulo 01246-000, Brazil

Sao Paulo 1323020, Brazil

Vandoeuvre-les-nancy 54511, France

Thessaloniki 56429, Greece

Bergamo 24128, Italy

Napoli 80131, Italy

Warszawa 01-201, Poland

Ponce 00716, Puerto Rico

San Juan 00921-3200, Puerto Rico

San Juan 00936-5067, Puerto Rico

Santurce 00909, Puerto Rico

Barcelona 08803, Spain

Taoyuan 333, Taiwan

Plymouth PL6 8DH, United Kingdom

Birmingham, Alabama 35295-0005, United States

La Jolla, California 92037-1030, United States

Long Beach, California 90822, United States

San Diego, California 92123, United States

San Diego, California 92154, United States

San Francisco, California 94115, United States

Aurora, Colorado 80045, United States

Gainesville, Florida 32610-0214, United States

Gainesville, Florida 32610, United States

Jacksonville, Florida 32209, United States

Miami, Florida 33136-1051, United States

Orlando, Florida 32809, United States

Orlando, Florida 32803, United States

Sarasota, Florida 34243, United States

Wellington, Florida 33414, United States

Atlanta, Georgia 30308, United States

Atlanta, Georgia 30309, United States

Marietta, Georgia 30060, United States

Honolulu, Hawaii 96817, United States

Boise, Idaho 83702, United States

Indianapolis, Indiana 46202, United States

Iowa City, Iowa 52242, United States

Kansas City, Kansas 66160, United States

Baltimore, Maryland 21205, United States

Framingham, Massachusetts 01702, United States

Worcester, Massachusetts 01655, United States

Plymouth, Minnesota 55446, United States

Newark, New Jersey 07102, United States

Vineland, New Jersey 08360, United States

Binghamton, New York 13903, United States

Manhasset, New York 11030, United States

New York, New York 10016, United States

New York, New York 10021, United States

Poughkeepsie, New York 12601, United States

Durham, North Carolina 27710, United States

Statesville, North Carolina 28677, United States

Cleveland, Ohio 44106, United States

Portland, Oregon 97201, United States

Lancaster, Pennsylvania 17604-3200, United States

Philadelphia, Pennsylvania 19104, United States

Providence, Rhode Island 02905, United States

Germantown, Tennessee 38138, United States

Dallas, Texas 75203, United States

Houston, Texas 77030, United States

San Antonio, Texas 78215, United States

Charlottesville, Virginia 22906-0013, United States

Bellevue, Washington 98004, United States

Seattle, Washington 98133, United States

Tacoma, Washington 98403, United States

Additional Information

Starting date: September 2003
Last updated: June 25, 2013

Page last updated: August 23, 2015

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