Clinical trial NCT01057667: A Study of RO5024048 in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 1 or 4
Official title: A Randomized, Double-blinded, Multicenter Study to Evaluate the Antiviral Efficacy and Safety of Adding the HCV Polymerase Inhibitor Prodrug (RO5024048) for 24 Weeks to the Currently Approved Combination of Pegasys® and Copegus® in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 or 4
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-01-27
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This equally randomized (1:1), double-blind, parallel arm study will assess the safety and antiviral efficacy of RO5024048 added to standard Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) therapy in patients with chronic hepatitis C genotype 1 or 4. Patients in arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily). Patients achieving a rapid virological response (RVR) at week 4, sustained through week 22, will stop all treatment at week 24; non-RVR patients will continue treatment with Pegasys and Copegus for another 24 weeks up to week 48. Patients in arm B will receive standard treatment with Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks. Anticipated time on study treatment is up to 48 weeks. Target sample size is \<200.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-70 years of age
* hepatitis C, genotype 1 or 4, of over 6 months duration
* treatment-naïve
* negative pregnancy test; female patients of childbearing age and male patients with female partners of childbearing age must use two forms of contraception during treatment and following the last dose of ribavirin in accordance with locally approved label for ribavirin

Exclusion Criteria:

* pregnant or breast feeding females or male partners of pregnant females
* previous interferon or ribavirin based therapy or investigational anti-HCV agent
* systemic antiviral therapy with established or perceived activity against HCV \</=3 months prior to first dose of study drug
* hepatitis A or B, or HIV infection
* history or evidence of medical condition associated with chronic liver disease other than HCV

Primary outcomes:
measure: Sustained virological response (undetectable HCV DNA as measured by Roche COBAS TaqMan HCV test)
timeFrame: 24 weeks after last treatment dose
Secondary outcomes:
measure: Virologic response over time
timeFrame: weeks 4, 12, 24, 36, 48 and 60
measure: Pharmacokinetics of RO4995855 when RO5024048 is administered with peginterferon alfa-2a and ribavirin
timeFrame: week 12 and 24
measure: Resistance profile of RO5024048
timeFrame: weeks 1-24
Other outcomes:
Locations:
city: La Jolla
country: United States
state: California
city: Bradenton
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Honolulu
country: United States
state: Hawaii
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Kansas City
country: United States
state: Kansas
city: Kansas City
country: United States
state: Missouri
city: Lebanon
country: United States
state: New Hampshire
city: Albuquerque
country: United States
state: New Mexico
city: Bronx
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Philadelphia
country: United States
state: Pennsylvania
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: Calgary
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: London
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
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.