DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



A Study of PEGASYS (Pegylated-interferon Alfa-2a) With or Without Ribavirin in Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols

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: Pegylated-interferon 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 Director, Affiliation: Hoffmann-La Roche

Summary

This single arm study will provide treatment or re-treatment with PEGASYS as monotherapy or in combination with ribavirin (Copegus), to patients with chronic hepatitis C (CHC) who have participated in a previous Roche or Roche partner protocol where access to treatment or re-treatment was promised or deemed appropriate following completion of the original protocol ('donor' protocol). Patients who qualify for treatment or re-treatment will begin PEGASYS monotherapy, at a maximum dose of 180 µg weekly, or combination therapy with Copegus, 800-1200 mg daily, as continuation of treatment after the wash-out period defined in their donor protocol. PEGASYS treatment is not to exceed the approved treatment duration of 48 weeks in genotype G1 with a treatment-free follow up period of 24 weeks.

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 Who Experienced 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 (CHC) patients with compensated liver disease (Child-Pugh A) who

have participated in a donor protocol where access to treatment or re-treatment with PEGASYS monotherapy or in combination with Copegus was promised or deemed appropriate after completion of the donor protocol. Exclusion Criteria:

- Evidence of decompensated liver disease (Child B or C cirrhosis).

Locations and Contacts

Wien 1090, Austria

Clichy 92118, France

Berlin 10969, Germany

Frankfurt Am Main 60590, Germany

Koeln 50924, Germany

Badalona 08915, Spain

Barcelona 08003, Spain

Madrid 28222, Spain

Valencia 46014, Spain

Vancouver, British Columbia V5Z 1M9, Canada

Vancouver, British Columbia V5Z 1H2, Canada

Sacramento, California 95817, United States

San Francisco, California 94115, United States

Lutherville, Maryland 21093, United States

Manhasset, New York 11030, United States

New York, New York 10021, United States

Chapel Hill, North Carolina 27599-7584, United States

Toronto, Ontario M5G 1L7, Canada

Portland, Oregon 97239, United States

Providence, Rhode Island 02905, United States

Nashville, Tennessee 37203, United States

San Antonio, Texas 78215, United States

Salt Lake City, Utah 84132, United States

Additional Information

Starting date: April 2009
Last updated: September 30, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017