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

Completed · Phase 3

Conditions studied: Hepatitis C, Chronic

In brief

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.

Key facts

Study ID

NCT00800735

Run by

Hoffmann-La Roche

People needed

30

Starts

2009-04-01

Expected to finish

2012-03-01

Last updated by the study team

2013-10-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Study site — Sacramento, California, United States
• Study site — San Francisco, California, United States
• Study site — Lutherville, Maryland, United States
• Study site — Manhasset, New York, United States
• Study site — New York, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Portland, Oregon, United States
• Study site — Providence, Rhode Island, United States
• Study site — Nashville, Tennessee, United States
• Study site — San Antonio, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Vienna, Austria
• Study site — Vancouver, British Columbia, Canada
• Study site — Vancouver, British Columbia, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Clichy, France
• Study site — Berlin, Germany
• Study site — Cologne, Germany
• Study site — Frankfurt am Main, Germany
• Study site — Badalona, Spain
• Study site — Barcelona, Spain
• Study site — Madrid, Spain
• Study site — Valencia, Spain

Full record on ClinicalTrials.gov

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