A Study of Mericitabine in Combination With Boceprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C
Status and phase
Completed
Phase 2
Conditions
Hepatitis C, Chronic
Treatments
Drug: boceprevir
Drug: boceprevir placebo
Drug: Copegus
Drug: mericitabine placebo
Drug: mericitabine
Drug: Pegasys
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
58 patients
Sex
All
Ages
18+ years old
Volunteers
No 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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
58 participants in 3 patient groups
Treatment Arm A
Experimental group
Description:
24 weeks of therapy with mericitabine 1000 mg twice a day (BID), boceprevir 800 mg three times daily (TID), Pegasys 180 microgram/week, and Copegus 1000/1200 mg/day (total treatment duration of 24 weeks), followed by a 24-week treatment-free follow-up period.
Treatment:
Drug: mericitabine
Drug: boceprevir
Drug: Pegasys
Drug: Copegus
Drug: boceprevir
Drug: boceprevir
Drug: Pegasys
Drug: Copegus
Treatment Arm B
Experimental group
Description:
24 weeks of therapy with mericitabine + boceprevir + Pegasys/Copegus followed by 24 weeks of therapy with boceprevir + Pegasys/Copegus (triple) (total treatment duration of 48 weeks), followed by a 24-week treatment-free follow-up period.
Treatment:
Drug: mericitabine
Drug: boceprevir
Drug: Pegasys
Drug: Copegus
Drug: boceprevir
Drug: boceprevir
Drug: Pegasys
Drug: Copegus
Treatment Arm C (Control)
Active Comparator group
Description:
4 weeks of therapy with mericitabine placebo, boceprevir placebo + Pegasys/Copegus, then 20 weeks of therapy with mericitabine placebo + boceprevir + Pegasys/Copegus, then 24 weeks of therapy with boceprevir + Pegasys/Copegus (total treatment duration of 48 weeks), followed by a 24-week treatment-free follow-up period.
Treatment:
Drug: boceprevir
Drug: mericitabine placebo
Drug: Pegasys
Drug: Copegus
Drug: boceprevir
Drug: boceprevir
Drug: boceprevir placebo
Drug: Pegasys
Drug: Copegus
Trial contacts and locations
24
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Data sourced from clinicaltrials.gov
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