A Study of Mericitabine in Combination With Boceprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C
NCT ID: NCT01482403
Last Updated: 2016-08-05
Study Results
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Basic Information
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COMPLETED
PHASE2
58 participants
INTERVENTIONAL
2011-11-30
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment Arm A
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.
Copegus
total daily dose of 1000 mg or 1200 mg for 24 weeks
Pegasys
180 microgram subcutaneous once a week for 24 weeks
boceprevir
800 mg three times a day for 24 weeks
mericitabine
1000 mg twice daily for 24 weeks
Treatment Arm B
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.
Copegus
total daily dose of 1000 mg or 1200 mg for 48 weeks
Pegasys
180 microgram subcutaneous once a week for 48 weeks
boceprevir
800 mg three times a day for 48 weeks
mericitabine
1000 mg twice daily for 24 weeks
Treatment Arm C (Control)
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.
Copegus
total daily dose of 1000 mg or 1200 mg for 48 weeks
Pegasys
180 microgram subcutaneous once a week for 48 weeks
mericitabine placebo
mericitabine placebo
boceprevir placebo
boceprevir placebo
boceprevir
800 mg three times a day for 44 weeks
Interventions
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Copegus
total daily dose of 1000 mg or 1200 mg for 24 weeks
Copegus
total daily dose of 1000 mg or 1200 mg for 48 weeks
Pegasys
180 microgram subcutaneous once a week for 24 weeks
Pegasys
180 microgram subcutaneous once a week for 48 weeks
boceprevir
800 mg three times a day for 24 weeks
boceprevir
800 mg three times a day for 48 weeks
mericitabine
1000 mg twice daily for 24 weeks
mericitabine placebo
mericitabine placebo
boceprevir placebo
boceprevir placebo
boceprevir
800 mg three times a day for 44 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Littleton, Colorado, United States
Chicago, Illinois, United States
Shreveport, Louisiana, United States
Detroit, Michigan, United States
Kansas City, Missouri, United States
San Antonio, Texas, United States
Chesapeake, Virginia, United States
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
London, Ontario, Canada
Créteil, , France
Nice, , France
Rennes, , France
Berlin, , Germany
Hamburg, , Germany
Hanover, , Germany
Napoli, Campania, Italy
Milan, Lombardy, Italy
Florence, Tuscany, Italy
Ponce, , Puerto Rico
Palma de Mallorca, Balearic Islands, Spain
Santander, Cantabria, Spain
Pontevedra, Pontevedra, Spain
Valencia, Valencia, Spain
Countries
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References
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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.
Other Identifiers
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2011-002714-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NV27780
Identifier Type: -
Identifier Source: org_study_id
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