Clinical trial NCT00087646: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2004-07-14
Enrollment: 948
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants With Sustained Virological Response Rate
timeFrame: Up to 72 weeks (Group A) and 48 weeks (Group D)
Secondary outcomes:
measure: Number of Participants With Sustained Virological Response (Groups A + B vs Groups C + D)
timeFrame: At Week 48 and Week 72
measure: Number of Participants With Sustained Virological Response (Groups A + C vs Groups B + D)
timeFrame: At Week 48 and Week 72
measure: Percentage of Participants With Undetectable HCV-RNA
timeFrame: At Week 12, 24, 48 and EOT
measure: Percentage of Participants With >=2log Drop in HCV-RNA
timeFrame: At Week 12 and 24
measure: Change From Baseline in Reduction of HCV Viremia (Groups A + B vs Groups C + D)
timeFrame: At Week 12 and 24
measure: Percentage of Participants With Maintenance of Actual End-of-Treatment Virological Response
timeFrame: Week 96 (Group A and C) and Week 72 (Group B and D)
measure: Percentage of Participants With Relapse After End of Treatment
timeFrame: Week 96 (Group A and C) and Week 72 (Group B and D)
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Scottsdale
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Pasadena
country: United States
state: California
city: San Diego
country: United States
state: California
city: Ukiah
country: United States
state: California
city: Farmington
country: United States
state: Connecticut
city: Bradenton
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Des Moines
country: United States
state: Iowa
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Minneapolis
country: United States
state: Minnesota
city: Rochester
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: Florham Park
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Williamsville
country: United States
state: New York
city: Lancaster
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Cranston
country: United States
state: Rhode Island
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Burlington
country: United States
state: Vermont
city: Richmond
country: United States
state: Virginia
city: Bruxelles
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Rio de Janeiro
country: Brazil
city: Vancouver
country: Canada
state: British Columbia
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Clichy
country: France
city: Creteil
country: France
city: Lille
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Montpellier
country: France
city: Paris
country: France
city: Pessac
country: France
city: Toulouse
country: France
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Bonn
country: Germany
city: Düsseldorf
country: Germany
city: Düsseldorf
country: Germany
city: Erlangen
country: Germany
city: Frankfurt Am Main
country: Germany
city: Freiburg
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Heidelberg
country: Germany
city: Homburg/saar
country: Germany
city: Kassel
country: Germany
city: Kiel
country: Germany
city: Köln
country: Germany
city: Mainz
country: Germany
city: Muenchen
country: Germany
city: Oberhausen
country: Germany
city: Wuerzburg
country: Germany
city: Alexandroupolis
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Thessaloniki
country: Greece
city: Bari
country: Italy
city: Bologna
country: Italy
city: Milano
country: Italy
city: Padova
country: Italy
city: Palermo
country: Italy
city: Roma
country: Italy
city: Torino
country: Italy
city: Coimbra
country: Portugal
city: Lisboa
country: Portugal
city: Lisboa
country: Portugal
city: Alicante
country: Spain
city: Barcelona
country: Spain
city: Granada
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Málaga
country: Spain
city: Santander
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Goeteborg
country: Sweden
city: Huddinge
country: Sweden
city: Lund
country: Sweden
city: Zürich
country: Switzerland
city: Ankara
country: Turkey
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Birmingham
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
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.