Back to resultsREPEAT Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Therapy in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Who Did Not Respond to Previous PegIntron (Peginterferon Alfa-2b (12KD))/Ribavirin Combination Therapy
Primary Purpose
Hepatitis C, Chronic
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Ribavirin
Ribavirin
peginterferon alfa-2a [Pegasys]
peginterferon alfa-2a [Pegasys]
peginterferon alfa-2a [Pegasys]
peginterferon alfa-2a [Pegasys]
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; CHC infection; liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection; use of 2 forms of contraception during study and 6 months after the study in both men and women; Lack of response to previous treatment with peginterferon alfa-2b (12KD)/ribavirin combination therapy given for >=12 weeks. Exclusion Criteria: women who are pregnant or breastfeeding; male partners of women who are pregnant; conditions associated with decompensated liver disease; other forms of liver disease, including liver cancer; human immunodeficiency virus infection.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
4
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Sustained Virological Response Rate
Sustained Virological Response (SVR) was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.
Secondary Outcome Measures
Number of Participants With Sustained Virological Response (Groups A + B vs Groups C + D)
SVR was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.
Number of Participants With Sustained Virological Response (Groups A + C vs Groups B + D)
SVR was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.
Percentage of Participants With Undetectable HCV-RNA
The percentage of participants with a undetectable HCV RNA 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 IU/mL measured >= 20 weeks after treatment end, ie, >=140 days after treatment end) are reported.
End-of-treatment (EOT) virological response is defined as last HCV RNA measurement that is not detectable (<50 IU/mL) at study day of last dose of study medication (+/- 28 days).
Percentage of Participants With >=2log Drop in HCV-RNA
Reduction in HCV-RNA titers of at least 2 log10 after 12/24 weeks of study treatment (i.e. 99% reduction of viral load) was analyzed. Percentage of participants with at least a 2 log10 drop of HCV-RNA at study week 12 and 24 (lower limit of quantitation 600 IU/mL) as compared to baseline or non-detectable HCV-RNA (lower limit of detection 50 IU/mL) were reported.
Change From Baseline in Reduction of HCV Viremia (Groups A + B vs Groups C + D)
The mean change from baseline in HCV RNA level (reduction in viral load) at Week 12 and 24 were determined. HCV RNA result were not detectable (<50 IU/ML) and not quantifiable (<600 IU/ML). Baseline value were assessed on Day 1 before the administration of the first dose of study drug.
Percentage of Participants With Maintenance of Actual End-of-Treatment Virological Response
Maintenance of end-of-treatment virological response was assessed based on all participants treated and according to the actual treatment period (backward imputation method). The percentage of participants who maintained their end-of-treatment virological response was determined. Maintenance of actual end-of-treatment virological response was calculated by dividing the number of participants with a virological response both at the end of the actual untreated follow-up period and at the end of the actual treatment period by the number of participants with a virological response at the actual end of treatment.
Percentage of Participants With Relapse After End of Treatment
The percentage of participants who relapsed (loss of response) after having achieved a virological response at the end of treatment was determined.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00087646
Brief Title
REPEAT Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Therapy in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Who Did Not Respond to Previous PegIntron (Peginterferon Alfa-2b (12KD))/Ribavirin Combination Therapy
Official Title
A Randomized, Open-label Study of the Effect of PEGASYS Combined With Ribavirin on Sustained Virologic Response in Patients With Chronic Hepatitis C Who Did Not Respond to Previous Pegintron/Ribavirin Combination Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (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 4 arm study is designed for patients with CHC who have not responded to peginterferon alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening the duration of treatment, as well as including an initial 12-week period of high-dose PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS (180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.
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 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
948 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
1000/1200mg po daily for 72 weeks
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
1000/1200mg po daily for 48 weeks
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 60 weeks
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 36 weeks.
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
180 micrograms sc weekly for 72 weeks
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
180 micrograms sc weekly for 48 weeks
Primary Outcome Measure Information:
Title
Number of Participants With Sustained Virological Response Rate
Description
Sustained Virological Response (SVR) was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.
Time Frame
Up to 72 weeks (Group A) and 48 weeks (Group D)
Secondary Outcome Measure Information:
Title
Number of Participants With Sustained Virological Response (Groups A + B vs Groups C + D)
Description
SVR was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.
Time Frame
At Week 48 and Week 72
Title
Number of Participants With Sustained Virological Response (Groups A + C vs Groups B + D)
Description
SVR was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.
Time Frame
At Week 48 and Week 72
Title
Percentage of Participants With Undetectable HCV-RNA
Description
The percentage of participants with a undetectable HCV RNA 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 IU/mL measured >= 20 weeks after treatment end, ie, >=140 days after treatment end) are reported.
End-of-treatment (EOT) virological response is defined as last HCV RNA measurement that is not detectable (<50 IU/mL) at study day of last dose of study medication (+/- 28 days).
Time Frame
At Week 12, 24, 48 and EOT
Title
Percentage of Participants With >=2log Drop in HCV-RNA
Description
Reduction in HCV-RNA titers of at least 2 log10 after 12/24 weeks of study treatment (i.e. 99% reduction of viral load) was analyzed. Percentage of participants with at least a 2 log10 drop of HCV-RNA at study week 12 and 24 (lower limit of quantitation 600 IU/mL) as compared to baseline or non-detectable HCV-RNA (lower limit of detection 50 IU/mL) were reported.
Time Frame
At Week 12 and 24
Title
Change From Baseline in Reduction of HCV Viremia (Groups A + B vs Groups C + D)
Description
The mean change from baseline in HCV RNA level (reduction in viral load) at Week 12 and 24 were determined. HCV RNA result were not detectable (<50 IU/ML) and not quantifiable (<600 IU/ML). Baseline value were assessed on Day 1 before the administration of the first dose of study drug.
Time Frame
At Week 12 and 24
Title
Percentage of Participants With Maintenance of Actual End-of-Treatment Virological Response
Description
Maintenance of end-of-treatment virological response was assessed based on all participants treated and according to the actual treatment period (backward imputation method). The percentage of participants who maintained their end-of-treatment virological response was determined. Maintenance of actual end-of-treatment virological response was calculated by dividing the number of participants with a virological response both at the end of the actual untreated follow-up period and at the end of the actual treatment period by the number of participants with a virological response at the actual end of treatment.
Time Frame
Week 96 (Group A and C) and Week 72 (Group B and D)
Title
Percentage of Participants With Relapse After End of Treatment
Description
The percentage of participants who relapsed (loss of response) after having achieved a virological response at the end of treatment was determined.
Time Frame
Week 96 (Group A and C) and Week 72 (Group B and D)
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;
CHC infection;
liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection;
use of 2 forms of contraception during study and 6 months after the study in both men and women;
Lack of response to previous treatment with peginterferon alfa-2b (12KD)/ribavirin combination therapy given for >=12 weeks.
Exclusion Criteria:
women who are pregnant or breastfeeding;
male partners of women who are pregnant;
conditions associated with decompensated liver disease;
other forms of liver disease, including liver cancer;
human immunodeficiency virus infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36693
Country
United States
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
Ukiah
State/Province
California
ZIP/Postal Code
95482
Country
United States
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
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
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50312
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404-4565
Country
United States
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Florham Park
State/Province
New Jersey
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
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
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Rio de Janeiro
ZIP/Postal Code
20270-901
Country
Brazil
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1H2
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M1
Country
Canada
City
Clichy
ZIP/Postal Code
92118
Country
France
City
Creteil
ZIP/Postal Code
94010
Country
France
City
Lille
ZIP/Postal Code
59037
Country
France
City
Lyon
ZIP/Postal Code
69288
Country
France
City
Marseille
ZIP/Postal Code
13385
Country
France
City
Montpellier
ZIP/Postal Code
34295
Country
France
City
Paris
ZIP/Postal Code
75651
Country
France
City
Pessac
ZIP/Postal Code
33604
Country
France
City
Toulouse
ZIP/Postal Code
31059
Country
France
City
Berlin
ZIP/Postal Code
13353
Country
Germany
City
Bochum
ZIP/Postal Code
44791
Country
Germany
City
Bonn
ZIP/Postal Code
53127
Country
Germany
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
City
Düsseldorf
ZIP/Postal Code
40237
Country
Germany
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
City
Frankfurt Am Main
ZIP/Postal Code
60596
Country
Germany
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
City
Hannover
ZIP/Postal Code
30625
Country
Germany
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
City
Homburg/saar
ZIP/Postal Code
66424
Country
Germany
City
Kassel
ZIP/Postal Code
34125
Country
Germany
City
Kiel
ZIP/Postal Code
24105
Country
Germany
City
Köln
ZIP/Postal Code
50937
Country
Germany
City
Mainz
ZIP/Postal Code
55101
Country
Germany
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
City
Oberhausen
ZIP/Postal Code
46145
Country
Germany
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
City
Alexandroupolis
ZIP/Postal Code
68100
Country
Greece
City
Athens
ZIP/Postal Code
10552
Country
Greece
City
Athens
ZIP/Postal Code
11527
Country
Greece
City
Thessaloniki
ZIP/Postal Code
546 42
Country
Greece
City
Bari
ZIP/Postal Code
70100
Country
Italy
City
Bologna
ZIP/Postal Code
40138
Country
Italy
City
Milano
ZIP/Postal Code
20122
Country
Italy
City
Padova
ZIP/Postal Code
35128
Country
Italy
City
Palermo
ZIP/Postal Code
90127
Country
Italy
City
Roma
ZIP/Postal Code
00133
Country
Italy
City
Torino
ZIP/Postal Code
10126
Country
Italy
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
City
Lisboa
ZIP/Postal Code
1150-314
Country
Portugal
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
City
Alicante
ZIP/Postal Code
03010
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Granada
ZIP/Postal Code
18003
Country
Spain
City
Madrid
ZIP/Postal Code
28007
Country
Spain
City
Madrid
ZIP/Postal Code
28035
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Málaga
ZIP/Postal Code
29010
Country
Spain
City
Santander
ZIP/Postal Code
39008
Country
Spain
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
City
Valencia
ZIP/Postal Code
46014
Country
Spain
City
Goeteborg
ZIP/Postal Code
41685
Country
Sweden
City
Huddinge
ZIP/Postal Code
14186
Country
Sweden
City
Lund
ZIP/Postal Code
22185
Country
Sweden
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
City
Istanbul
ZIP/Postal Code
81190
Country
Turkey
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
23442834
Citation
Marcellin P, Craxi A, Brandao-Mello CE, Di Bisceglie AM, Andreone P, Freilich B, Rajender Reddy K, Olveira Martin A, Teuber G, Messinger D, Hooper G, Wat C, Tatsch F, Jensen DM. Predicting early and sustained virological responses in prior nonresponders to pegylated interferon alpha-2b plus ribavirin retreated with peginterferon alpha-2a plus ribavirin and the benefit-risk ratio of retreatment. J Clin Gastroenterol. 2013 Oct;47(9):786-93. doi: 10.1097/MCG.0b013e31827b9b45.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/19380853
Description
This is a full publication titled Re-treatment of Patients With Chronic Hepatitis C Who Do Not Respond to Peginterferon- alfa2b, A Randomized Trial
Learn more about this trial
REPEAT Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Therapy in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Who Did Not Respond to Previous PegIntron (Peginterferon Alfa-2b (12KD))/Ribavirin Combination Therapy
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