Clinical trial NCT00869661: A Study of RO5024048 in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C, Genotype 1 or 4
Official title: A Randomized, Double-blind, Multicenter, Dose and Duration Finding Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug (RO5024048) in Combination With Pegasys® and Ribavirin® (SOC) Versus SOC in Treatment-Naïve Patients With HCV Genotype 1 or 4 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-03-26
Enrollment: 413
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 6-arm study will assess the efficacy and safety of RO5024048 (R7128) in combination with the approved doses of Pegasys (180micrograms sc weekly) + Copegus (1000/1200mg po daily) (SOC), versus SOC in treatment-naive patients with chronic hepatitis C, genotype 1 and 4. The first 3 groups will receive 1) RO5024048 500mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks; 2)RO5024048 1000mg bid + Pegasys + Copegus for 8 weeks, followed by SOC for 16 weeks; 3) RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks. After 24 weeks, patients in these 3 groups who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks. Group 4 will receive RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 36 weeks, and group 5 will receive SOC for 48 weeks. Group 6 provides retreatment on an open-label basis for patients of Group 5 who failed treatment. Patients will receive RO5024048 1000mg bid + Pegasys + Copegus for 24 weeks, followed by SOC for 24 weeks. The anticipated time on study treatment is 6-12 months.


Eligibility criteria: Inclusion Criteria:

* Adult patients, 18-65 years of age
* Chronic hepatitis C, genotype 1 or 4
* Treatment-naive

Exclusion Criteria:

* No previous treatment with any interferon- or ribavirin-based therapy
* Other forms of liver disease
* HIV infection

Primary outcomes:
measure: Sustained virologic response: Percentage of patients with undetectable Hepatitis C RNA level
timeFrame: 24 weeks after end of treatment
Secondary outcomes:
measure: Virologic response: Percentage of patients with undetectable Hepatitis C RNA level
timeFrame: 60 Weeks
measure: Virologic response: Percentage of patients with undetectable Hepatitis C RNA level
timeFrame: 12 weeks post-treatment
measure: Relapse rate: Percentage of patients who achieved a virologic response at the end of treatment but had detectable Hepatitis C RNA level at the last assessment post treatment
timeFrame: 72 weeks
measure: Safety: Incidence of adverse events
timeFrame: 72 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
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: Washington
country: United States
state: District of Columbia
city: Bradenton
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Lutherville
country: United States
state: Maryland
city: Kansas City
country: United States
state: Missouri
city: Newark
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Hershey
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Columbia
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Sydney
country: Australia
state: New South Wales
city: Greenslopes
country: Australia
state: Queensland
city: Herston
country: Australia
state: Queensland
city: Woolloongabba
country: Australia
state: Queensland
city: Fitzroy
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Nedlands
country: Australia
state: Western Australia
city: Perth
country: Australia
state: Western Australia
city: Wien
country: Austria
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Creteil
country: France
city: La Tronche
country: France
city: Lille
country: France
city: Nice
country: France
city: Paris
country: France
city: Paris
country: France
city: Pessac
country: France
city: Vandoeuvre-les-nancy
country: France
city: Berlin
country: Germany
city: Frankfurt Am Main
country: Germany
city: Freiburg
country: Germany
city: Hannover
country: Germany
city: Muenchen
country: Germany
city: Ulm
country: Germany
city: Bologna
country: Italy
state: Emilia-Romagna
city: Milano
country: Italy
state: Lombardia
city: Torino
country: Italy
state: Piemonte
city: Pisa
country: Italy
state: Toscana
city: Santurce
country: Puerto Rico
city: Badalona
country: Spain
state: Barcelona
city: La Coruna
country: Spain
state: La Coruña
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Granada
country: Spain
city: Madrid
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: London
country: United Kingdom
city: London
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Tong X, Le Pogam S, Li L, Haines K, Piso K, Baronas V, Yan JM, So SS, Klumpp K, Najera I. In vivo emergence of a novel mutant L159F/L320F in the NS5B polymerase confers low-level resistance to the HCV polymerase inhibitors mericitabine and sofosbuvir. J Infect Dis. 2014 Mar 1;209(5):668-75. doi: 10.1093/infdis/jit562. Epub 2013 Oct 23.