Clinical trial NCT01482403: A Study of Mericitabine in Combination With Boceprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C
Official title: A Phase II, Randomized, Double-Blind, Multicenter, Parallel Group Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug RO5024048 in Combination With Boceprevir and Pegasys®/Copegus® in Patients With Chronic Hepatitis C Genotype 1 Virus Infection Who Were Prior Null Responders to Treatment With Pegylated Interferon/Ribavirin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-11-30
Enrollment: 58
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, double-blind, multi-center, placebo-controlled, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) in combination with boceprevir and Pegasys/Copegus in patients with chronic hepatitis C infection. The anticipated time on study treatment is up to 48 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Chronic hepatitis C infection for at least 6 months duration
* Hepatitis C genotype 1a or 1b
* Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to enrollment in this study
* Patient showed a previous null response to therapy as defined by \< 2 log10 IU/mL decrease in viral titer after at least 12 weeks of treatment with PEG-IFN/RBV

Exclusion Criteria:

* Hepatitis C infection with a genotype other than genotype 1a or 1b
* Body mass index \<18 or \>/=36
* Hepatitis A, hepatitis B, or HIV infection
* Herbal remedies \</=1 month prior to the first dose of study drug

Primary outcomes:
measure: Sustained virological response 12 weeks after treatment (SVR-12)
timeFrame: up to 60 weeks
Secondary outcomes:
measure: Sustained virological response 4 weeks after treatment
timeFrame: up to 52 weeks
measure: Virologic response over time
timeFrame: 60 weeks
measure: Proportion of patients who develop treatment resistance
timeFrame: 60 weeks
measure: Safety (incidence of adverse events)
timeFrame: 60 weeks
measure: Pharmacokinetics: trough concentration of RO4995855
timeFrame: Day 1 and Week 8
measure: Pharmacokinetics: trough concentration of RO5012433
timeFrame: Day 1 and Week 8
measure: Pharmacokinetics: trough concentration of boceprevir
timeFrame: Day 1 and Week 8
Other outcomes:
Locations:
city: Littleton
country: United States
state: Colorado
city: Chicago
country: United States
state: Illinois
city: Shreveport
country: United States
state: Louisiana
city: Detroit
country: United States
state: Michigan
city: Kansas City
country: United States
state: Missouri
city: San Antonio
country: United States
state: Texas
city: Chesapeake
country: United States
state: Virginia
city: Calgary
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: London
country: Canada
state: Ontario
city: Creteil
country: France
city: Nice
country: France
city: Rennes
country: France
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Napoli
country: Italy
state: Campania
city: Milano
country: Italy
state: Lombardia
city: Firenze
country: Italy
state: Toscana
city: Ponce
country: Puerto Rico
city: Santander
country: Spain
state: Cantabria
city: Palma de Mallorca
country: Spain
state: Islas Baleares
city: Pontevedra
country: Spain
city: Valencia
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Wedemeyer H, Forns X, Hezode C, Lee SS, Scalori A, Voulgari A, Le Pogam S, Najera I, Thommes JA. Mericitabine and Either Boceprevir or Telaprevir in Combination with Peginterferon Alfa-2a plus Ribavirin for Patients with Chronic Hepatitis C Genotype 1 Infection and Prior Null Response: The Randomized DYNAMO 1 and DYNAMO 2 Studies. PLoS One. 2016 Jan 11;11(1):e0145409. doi: 10.1371/journal.pone.0145409. eCollection 2016.