Back to resultsA 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
Primary Purpose
Hepatitis C, Chronic
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Peginterferon alfa-2a
Ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C, Chronic
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Peginterferon alfa-2a monotherapy or combined with ribavirin
Arm Description
The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
Outcomes
Primary Outcome Measures
Percentage of Participants With at Least 1 Adverse Event
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01853254
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
272 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peginterferon alfa-2a monotherapy or combined with ribavirin
Arm Type
Experimental
Arm Description
The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a
Other Intervention Name(s)
Pegasys
Intervention Description
Both combination and monotherapy for both genotype 2/3 and genotype non-2/3: 180 μg subcutaneously once weekly.
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Copegus
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With at Least 1 Adverse Event
Time Frame
From Baseline to the end of the study (up to 72 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35295-0005
Country
United States
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-1030
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92154
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0214
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136-1051
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
City
Framingham
State/Province
Massachusetts
ZIP/Postal Code
01702
Country
United States
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
City
Vineland
State/Province
New Jersey
ZIP/Postal Code
08360
Country
United States
City
Binghamton
State/Province
New York
ZIP/Postal Code
13903
Country
United States
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28677
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604-3200
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22906-0013
Country
United States
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98403
Country
United States
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
City
Herston
ZIP/Postal Code
4006
Country
Australia
City
Ribeirao Preto
ZIP/Postal Code
14049-900
Country
Brazil
City
Salvador
ZIP/Postal Code
40150-130
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
1323020
Country
Brazil
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54511
Country
France
City
Thessaloniki
ZIP/Postal Code
56429
Country
Greece
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
City
Napoli
ZIP/Postal Code
80131
Country
Italy
City
Warszawa
ZIP/Postal Code
01-201
Country
Poland
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
City
San Juan
ZIP/Postal Code
00921-3200
Country
Puerto Rico
City
San Juan
ZIP/Postal Code
00936-5067
Country
Puerto Rico
City
Santurce
ZIP/Postal Code
00909
Country
Puerto Rico
City
Barcelona
ZIP/Postal Code
08803
Country
Spain
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
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
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