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

Phase 3

Completed

• Conditions: Hepatitis C, Chronic
• Interventions: Drug: Pegylated-interferon alfa-2a; Drug: Ribavirin

• Registration Number: NCT00800735
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-23
• Study First Submitted QC: 2008-12-01
• Study First Posted: 2008-12-02
• Study Start: 2009-04
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Results First Submitted: 2013-07-05
• Results First Submitted QC: 2013-07-05
• Status Verified: 2013-09
• Results First Posted: 2013-09-13
• Last Update Submitted: 2013-09-30
• Last Update Posted: 2013-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pegylated-interferon alfa-2a plus ribavirin	Pegylated-interferon alfa-2a	Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing \< 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
Pegylated-interferon alfa-2a plus ribavirin	Ribavirin	Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing \< 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Experienced at Least 1 Adverse Event.	Baseline through 24 weeks after the end of treatment (up to 72 weeks)	An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.