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
2 other identifiers
interventional
58
7 countries
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2011
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 28, 2011
CompletedFirst Posted
Study publicly available on registry
November 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedAugust 5, 2016
August 1, 2016
2.2 years
November 28, 2011
August 3, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Sustained virological response 12 weeks after treatment (SVR-12)
up to 60 weeks
Secondary Outcomes (7)
Sustained virological response 4 weeks after treatment
up to 52 weeks
Virologic response over time
60 weeks
Proportion of patients who develop treatment resistance
60 weeks
Safety (incidence of adverse events)
60 weeks
Pharmacokinetics: trough concentration of RO4995855
Day 1 and Week 8
- +2 more secondary outcomes
Study Arms (3)
Treatment Arm A
EXPERIMENTAL24 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 Arm B
EXPERIMENTAL24 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 Arm C (Control)
ACTIVE COMPARATOR4 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Unknown Facility
Littleton, Colorado, 80120, United States
Unknown Facility
Chicago, Illinois, 60637, United States
Unknown Facility
Shreveport, Louisiana, 71130, United States
Unknown Facility
Detroit, Michigan, 48202, United States
Unknown Facility
Kansas City, Missouri, 64128, United States
Unknown Facility
San Antonio, Texas, 78215, United States
Unknown Facility
Chesapeake, Virginia, 23320-1706, United States
Unknown Facility
Calgary, Alberta, T2N 4Z6, Canada
Unknown Facility
Vancouver, British Columbia, V5Z 1H2, Canada
Unknown Facility
London, Ontario, N6A 5A5, Canada
Unknown Facility
Créteil, 94010, France
Unknown Facility
Nice, 06202, France
Unknown Facility
Rennes, 35033, France
Unknown Facility
Berlin, 13353, Germany
Unknown Facility
Hamburg, 20099, Germany
Unknown Facility
Hanover, 30625, Germany
Unknown Facility
Napoli, Campania, 80131, Italy
Unknown Facility
Milan, Lombardy, 20121, Italy
Unknown Facility
Florence, Tuscany, 50134, Italy
Unknown Facility
Ponce, 00716, Puerto Rico
Unknown Facility
Palma de Mallorca, Balearic Islands, 07010, Spain
Unknown Facility
Santander, Cantabria, 39008, Spain
Unknown Facility
Pontevedra, Pontevedra, 36071, Spain
Unknown Facility
Valencia, Valencia, 46014, Spain
Related Publications (1)
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.
PMID: 26752189DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2011
First Posted
November 30, 2011
Study Start
November 1, 2011
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
August 5, 2016
Record last verified: 2016-08