A Study of Pegasys (Peginterferon Alfa-2a) Administered Alone or in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C Who Have Participated in Previous Pegasys Trials

Hepatitis C, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01853254
• Other study ID #: NV17590
• Status: Completed
• Phase: Phase 3
• First received: May 10, 2013
• Last updated: June 25, 2013
• Start date: September 2003
• Est. completion date: September 2011

Study information

• Verified date: June 2013
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This open-label, non-randomized, single arm study will provide treatment or re-treatment with Pegasys (peginterferon alfa-2a) as monotherapy or in combination with Copegus (ribavirin) to patients with chronic hepatitis C infection. Patients who have received prior Pegasys monotherapy or combination therapy or who were considered eligible for treatment with Pegasys in previous donor protocols will be eligible to participate in this study. Treatment will be on investigator's decision according to the approved label for up to 48 weeks, with a 24-week safety follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, = 18 years of age.

• Chronic hepatitis C.

• Compensated liver disease (Child-Pugh Class A).

• Previous participation in a donor protocol in which treatment or re-treatment with Pegasys alone or in combination with Copegus was recommended or deemed appropriate after study completion.

• Have completed safety and efficacy assessments as defined in the donor protocol without violation or any major deviation.

• Have not received any other anti-hepatitis C virus treatment after the completion of the donor protocol.

• For females of childbearing potential, a negative pregnancy test within 24 hours prior to first dose of study drug.

• Fertile patients (male and female) must use 2 reliable forms of contraception (combined) for the duration of the study (treatment and follow-up) in accordance with the locally approved label for Copegus.

Exclusion Criteria:

• Pregnant or breastfeeding women.

• Male partners of women who are pregnant.

• Patients with hemoglobinopathies.

• Hepatic decompensation (Child-Pugh Class B or C) before or during treatment.

• Non-responder patients (defined as patients previously treated with Pegasys and Copegus combination therapy at standard doses for at least 12 weeks who did not achieve at least a 2-log drop from their baseline viral load).

• Liver disease other than chronic hepatitis C, including hepatic carcinoma.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Peginterferon alfa-2a
Both combination and monotherapy for both genotype 2/3 and genotype non-2/3: 180 µg subcutaneously once weekly.
• Ribavirin
For genotype 2/3, 800 mg orally daily, in 2 split doses for 24 weeks. For genotype non-2/3, 1000 mg orally daily for participants weighing < 75 kg or 1200 mg orally daily for participants weighing = 75 kg, in 2 split doses, for 48 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  France,  Greece,  Italy,  Poland,  Puerto Rico,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With at Least 1 Adverse Event		From Baseline to the end of the study (up to 72 weeks)	Yes