Clinical trial NCT01220947: A Study of Danoprevir Boosted With Low Dose Ritonavir in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Virus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-10-14
Enrollment: 421
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 randomized, open-label, active-controlled, parallel-group study will evaluate the sustained virological response of danoprevir boosted with low dose ritonavir in combination with Pegasys (peginterferon alfa-2a) and Copegus versus Pegasys and Copegus alone in treatment-naive patients with chronic Hepatitis C.


Eligibility criteria: Inclusion Criteria:

* Adults patients, \>/=18 years of age
* Chronic Hepatitis C, Genotype 1 and 4
* HCV RNA \>/=50,000 IU/mL
* treatment-naive

Exclusion Criteria:

* Patients with cirrhosis or incomplete/transition to cirrhosis
* Patients with other forms of liver disease, HIV infection, hepatocellular carcinoma or severe cardiac disease

Primary outcomes:
measure: Sustained virological response (HCV RNA measured by Roche COBAS TaqMan HCV test)
timeFrame: 24 weeks after end of treatment
Secondary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: from baseline up to 72 weeks
measure: Evaluation of relapse rate
timeFrame: up to 24 weeks after end of treatment
measure: Characterization of resistance profile (HCV RNA sequencing and/or phenotypic analyses)
timeFrame: from baseline up to 72 weeks
measure: Virological response at scheduled visits over time (HCV RNA measured by Roche COBAS TaqMan HCV test)
timeFrame: From baseline up to 72 weeks
measure: Evaluation of virological breakthrough (viral load rebound) rate
timeFrame: up to 72 weeks
measure: Evaluation of pharmacokinetics (serum concentrations assessed by validated methods)
timeFrame: up to 72 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Orlando
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Decatur
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Chicago
country: United States
state: Illinois
city: Lutherville
country: United States
state: Maryland
city: Detroit
country: United States
state: Michigan
city: Bronx
country: United States
state: New York
city: Manhasset
country: United States
state: New York
city: New York
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Fayetteville
country: United States
state: North Carolina
city: Medford
country: United States
state: Oregon
city: Providence
country: United States
state: Rhode Island
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Newport News
country: United States
state: Virginia
city: Wien
country: Austria
city: Salvador
country: Brazil
state: BA
city: Porto Alegre
country: Brazil
state: RS
city: Ribeirao Preto
country: Brazil
state: SP
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Clichy
country: France
city: Creteil
country: France
city: Marseille
country: France
city: Paris
country: France
city: Rennes
country: France
city: Toulouse
country: France
city: Vandoeuvre-les-nancy
country: France
city: Berlin
country: Germany
city: Frankfurt Am Main
country: Germany
city: Freiburg
country: Germany
city: Hamburg
country: Germany
city: Leipzig
country: Germany
city: Wuerzburg
country: Germany
city: Napoli
country: Italy
state: Campania
city: Bologna
country: Italy
state: Emilia-Romagna
city: Milano
country: Italy
state: Lombardia
city: Pavia
country: Italy
state: Lombardia
city: Novara
country: Italy
state: Piemonte
city: Bari
country: Italy
state: Puglia
city: Guadalajara
country: Mexico
city: Monterrey
country: Mexico
city: Santurce
country: Puerto Rico
city: Badalona
country: Spain
state: Barcelona
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Sevilla
country: Spain
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Nottingham
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: