Status:

COMPLETED

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

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Hepatitis C, Chronic

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

April 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2012

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT00800735

Start Date

April 1 2009

End Date

March 1 2012

Last Update

October 30 2013

Active Locations (23)

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Page 1 of 6 (23 locations)

1

Sacramento, California, United States, 95817

2

San Francisco, California, United States, 94115

3

Lutherville, Maryland, United States, 21093

4

Manhasset, New York, United States, 11030