A Study of Mericitabine in Combination With Boceprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01482403

Enrollment

Registered

2011-11-30

Start date

2011-11-30

Completion date

2014-01-31

Last updated

2016-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic

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.

Interventions

DRUGCopegus

total daily dose of 1000 mg or 1200 mg for 24 weeks

DRUGPegasys

180 microgram subcutaneous once a week for 24 weeks

DRUGboceprevir

800 mg three times a day for 24 weeks

DRUGmericitabine

1000 mg twice daily for 24 weeks

DRUGmericitabine placebo

mericitabine placebo

DRUGboceprevir placebo

boceprevir placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Sustained virological response 12 weeks after treatment (SVR-12)	up to 60 weeks

Secondary

Measure	Time frame
Virologic response over time	60 weeks
Proportion of patients who develop treatment resistance	60 weeks
Safety (incidence of adverse events)	60 weeks
Sustained virological response 4 weeks after treatment	up to 52 weeks
Pharmacokinetics: trough concentration of RO5012433	Day 1 and Week 8
Pharmacokinetics: trough concentration of boceprevir	Day 1 and Week 8
Pharmacokinetics: trough concentration of RO4995855	Day 1 and Week 8

Countries

Canada, France, Germany, Italy, Puerto Rico, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026