A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C
NCT ID: NCT01482390
Last Updated: 2017-04-24
Study Results
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Basic Information
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COMPLETED
PHASE2
80 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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TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (24 Weeks)
Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with MCB and PEG-IFN/RBV (total treatment duration of 24 weeks).
Ribavirin
Participants will receive a total daily dose of 1000 milligrams (mg) (for participants weighing less than \[\<\] 75 kg) or 1200 mg (for participants weighing greater than or equal to \[\>=\] 75 kg) orally for 24 or 48 weeks.
Mericitabine
Participants will receive mericitabine 1000 mg orally twice daily.
Peginterferon Alfa-2a
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
Telaprevir
Participants will receive telaprevir 750 mg orally three times daily.
TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (48 Weeks)
Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with MCB and PEG-IFN/RBV and then 12 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks).
Ribavirin
Participants will receive a total daily dose of 1000 milligrams (mg) (for participants weighing less than \[\<\] 75 kg) or 1200 mg (for participants weighing greater than or equal to \[\>=\] 75 kg) orally for 24 or 48 weeks.
Mericitabine
Participants will receive mericitabine 1000 mg orally twice daily.
Peginterferon Alfa-2a
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
Telaprevir
Participants will receive telaprevir 750 mg orally three times daily.
TVR, MCB, Placebo MCB( each for 12Weeks),PEG-IFN/RBV(48 Weeks)
Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with placebo matching to MCB and PEG-IFN/RBV, and then 24 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks).
Ribavirin
Participants will receive a total daily dose of 1000 milligrams (mg) (for participants weighing less than \[\<\] 75 kg) or 1200 mg (for participants weighing greater than or equal to \[\>=\] 75 kg) orally for 24 or 48 weeks.
Mericitabine
Participants will receive mericitabine 1000 mg orally twice daily.
Peginterferon Alfa-2a
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
Placebo
Participants will receive placebo matching to mericitabine orally twice daily.
Telaprevir
Participants will receive telaprevir 750 mg orally three times daily.
TVR(12 Weeks), Placebo MCB (24 Weeks), PEG-IFN/RBV(48 Weeks)
Twelve weeks of therapy with placebo matching to MCB, TVR, PEG-IFN/RBV, will be followed by 12 weeks of therapy with placebo matching to MCB along with PEG-IFN/RBV , following 24 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks).
Ribavirin
Participants will receive a total daily dose of 1000 milligrams (mg) (for participants weighing less than \[\<\] 75 kg) or 1200 mg (for participants weighing greater than or equal to \[\>=\] 75 kg) orally for 24 or 48 weeks.
Peginterferon Alfa-2a
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
Placebo
Participants will receive placebo matching to mericitabine orally twice daily.
Telaprevir
Participants will receive telaprevir 750 mg orally three times daily.
Interventions
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Ribavirin
Participants will receive a total daily dose of 1000 milligrams (mg) (for participants weighing less than \[\<\] 75 kg) or 1200 mg (for participants weighing greater than or equal to \[\>=\] 75 kg) orally for 24 or 48 weeks.
Mericitabine
Participants will receive mericitabine 1000 mg orally twice daily.
Peginterferon Alfa-2a
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
Placebo
Participants will receive placebo matching to mericitabine orally twice daily.
Telaprevir
Participants will receive telaprevir 750 mg orally three times daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hepatitis C genotype 1a or 1b
* Participants must have discontinued prior hepatitis C treatment at least 12 weeks prior to enrollment in this study
* Participants showed a previous null response to therapy as defined by \< 2 logarithm to the base 10 (log10) international units per milliliter (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 kilograms per square meters (kg/m\^2)
* Hepatitis A, hepatitis B, or human immunodeficiency virus (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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Birmingham Gastro Associates, P.C.
Birmingham, Alabama, United States
VA Long Beach Healthcare System
Long Beach, California, United States
Kaiser Permanente Sacramento Medical Center
Sacramento, California, United States
UCSD Antiviral Research Center
San Diego, California, United States
Yale University
New Haven, Connecticut, United States
Gastroenterology Group of Naples
Naples, Florida, United States
John Hopkins Hospital
Lutherville, Maryland, United States
Metrowest Medical Center
Framingham, Massachusetts, United States
Saint Louis University Gastroenterology & Hepatology; Clinical Research Unit
St Louis, Missouri, United States
Weill Cornell Medical College
New York, New York, United States
Carolina'S Center For Liver Disease
Statesville, North Carolina, United States
Uni of Cincinnati College of Medicine; Div. of Digestive Diseases
Cincinnati, Ohio, United States
Baylor Uni Medical Center; Division Of Hepatology/Transplantation; Annette C. and Harold C. Simmons
Dallas, Texas, United States
McGuire; Veteran Affairs Med Ctr
Richmond, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States
Gordon & Leslie Diamond Health Care Centre; Dept. of Medicine - Division of Gastroenterology
Vancouver, British Columbia, Canada
GI Research Institute; Gastroenterology & Hepatology
Vancouver, British Columbia, Canada
Percuro Clinical Research Ltd.
Victoria, British Columbia, Canada
Winnipeg Regional Health Authority; Section of Hepatology
Winnipeg, Manitoba, Canada
University Health Network - Toronto Western Hospital; Hepatology
Toronto, Ontario, Canada
Toronto Digest. Disease Asso.
Woodbridge, Ontario, Canada
McGill University, Montreal Chest Institute; Viral and other Infectious
Montreal, Quebec, Canada
Hopital Claude Huriez;Gastro Enterologie
Lille, , France
Fondation Hopital Saint Joseph; Gastro-Enterologie
Marseille, , France
Hopital Purpan;Gastro Enterologie Hepatologie
Toulouse, , France
Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I
Frankfurt am Main, , Germany
Uniklinik Freiburg; Abteilung Innere Medizin II
Freiburg im Breisgau, , Germany
Universitäts Klinikum; Schleswig-Holstein Kiel
Kiel, , Germany
UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In
Bologna, Emilia-Romagna, Italy
ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Divisione Malattie Infettive
Milan, Lombardy, Italy
Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia
Pisa, Tuscany, Italy
Hospital Universitario de Canarias; Servicio de Digestivo
San Cristóbal de La Laguna, Tenerife, Spain
Hospital Universitari Vall d'Hebron; Departamento de Enfermedades Infecciosas
Barcelona, , Spain
Hospital Clinic I Provincial; Servicio de Digestivo
Barcelona, , Spain
Hospital Carlos III; Laboratorio de Biologia Molecular
Madrid, , Spain
Royal Bournemouth Hospital, Gastroenterology
Dorset, , United Kingdom
King'S College Hospital; Institute of Liver Studies
London, , United Kingdom
St George's Hospital
London, , United Kingdom
Imperial College Healthcare NHS Trust; Hepatology Clinical Research Facility
London, , United Kingdom
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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2011-002715-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NV27779
Identifier Type: -
Identifier Source: org_study_id
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