A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) With or Without Ribavirin in Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols.
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | April 2009 |
| End Date: | February 2011 |
| Contact: | Please reference Study ID Number: NV21928 |
| Email: | genentechclinicaltrials@druginfo.com |
| Phone: | 888-662-6728 (U.S. Only) |
An Open-label Study of the Safety of Pegasys Alone or in Combination With Ribavirin in Patients With Chronic Hepatitis C Who Have Participated in Previous Studies
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 micrograms weekly, or combination therapy with
Copegus ,800-1200mg daily, as continuation of treatment after the wash-out period defined in
their donor protocol. PEGASYS treatment is not to exceed approved treatment duration of 24
weeks in genotype 2/3 and 48 weeks in genotype non-2/3 with a treatment-free follow up
period of 24 weeks. The anticipated time on study treatment is 3-12 months, and the target
sample size is 100-500 individuals.
Inclusion Criteria:
- adult patients, >=18 years of age;
- 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).
We found this trial at
10
sites
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