Phase 3
Completed N=30
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
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00800735 ↗
Enrolled (actual)
30
Serious AEs
13.3%
Results posted
Sep 2013
Primary outcomePrimary: Percentage of Participants Who Experienced at Least 1 Adverse Event. — 80.0 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experienced at Least 1 Adverse Event. |
80.0 | — |
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT00800735). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.