Back to resultsA Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C
Primary Purpose
Hepatitis C
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ribavirin
Mericitabine
Peginterferon Alfa-2a
Placebo
Telaprevir
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C
Eligibility Criteria
Inclusion Criteria:
- Chronic hepatitis C infection for at least 6 months duration
- 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:
- Hepatitis C infection with a genotype other than genotype 1a or 1b
- 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
Sites / Locations
- Birmingham Gastro Associates, P.C.
- VA Long Beach Healthcare System
- Kaiser Permanente Sacramento Medical Center
- UCSD Antiviral Research Center
- Yale University
- Gastroenterology Group of Naples
- John Hopkins Hospital
- Metrowest Medical Center
- Saint Louis University Gastroenterology & Hepatology; Clinical Research Unit
- Weill Cornell Medical College
- Carolina'S Center For Liver Disease
- Uni of Cincinnati College of Medicine; Div. of Digestive Diseases
- Baylor Uni Medical Center; Division Of Hepatology/Transplantation; Annette C. and Harold C. Simmons
- McGuire; Veteran Affairs Med Ctr
- Harborview Medical Center
- Gordon & Leslie Diamond Health Care Centre; Dept. of Medicine - Division of Gastroenterology
- GI Research Institute; Gastroenterology & Hepatology
- Percuro Clinical Research Ltd.
- Winnipeg Regional Health Authority; Section of Hepatology
- University Health Network - Toronto Western Hospital; Hepatology
- Toronto Digest. Disease Asso.
- McGill University, Montreal Chest Institute; Viral and other Infectious
- Hopital Claude Huriez;Gastro Enterologie
- Fondation Hopital Saint Joseph; Gastro-Enterologie
- Hopital Purpan;Gastro Enterologie Hepatologie
- Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I
- Uniklinik Freiburg; Abteilung Innere Medizin II
- Universitäts Klinikum; Schleswig-Holstein Kiel
- UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In
- ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Divisione Malattie Infettive
- Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia
- Hospital Universitario de Canarias; Servicio de Digestivo
- Hospital Universitari Vall d'Hebron; Departamento de Enfermedades Infecciosas
- Hospital Clinic I Provincial; Servicio de Digestivo
- Hospital Carlos III; Laboratorio de Biologia Molecular
- Royal Bournemouth Hospital, Gastroenterology
- King'S College Hospital; Institute of Liver Studies
- St George's Hospital
- Imperial College Healthcare NHS Trust; Hepatology Clinical Research Facility
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (24 Weeks)
TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (48 Weeks)
TVR, MCB, Placebo MCB( each for 12Weeks),PEG-IFN/RBV(48 Weeks)
TVR(12 Weeks), Placebo MCB (24 Weeks), PEG-IFN/RBV(48 Weeks)
Arm Description
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).
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).
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).
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).
Outcomes
Primary Outcome Measures
Percent of Participants With Sustained Virological Response 12 Weeks After End of Treatment (SVR12), as Determined by Polymerase Chain Reaction (PCR) Using Roche COBAS TaqMan Hepatitis C Virus (HCV) Test
Secondary Outcome Measures
Percentage of Participants With Sustained Virological Response 4 Weeks After End of Treatment (SVR-4), as Determined by PCR Using Roche COBAS TaqMan HCV Test
Percentage of Participants With Sustained Virological Response 24 Weeks After End of Treatment (SVR-24), as Determined by PCR Using Roche COBAS TaqMan HCV Test
Percentage of Participants With Virological Response Over Time From Week 2 to Week 48, as Determined by PCR Using Roche COBAS TaqMan HCV Test
Percentage of Participants With Treatment- Resistant Mutations, as Determined Using Standard Sequencing Technology
Change From Baseline in HCV Ribonucleic Acid (RNA) Levels
Percentage of Participants With Adverse Event
Trough Concentration of RO4995855 (Parent Drug of Mericitabine)
Trough Concentration of Metabolite of RO4995855 (RO5012433)
Trough Concentration of Telaprevir
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01482390
Brief Title
A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C
Official Title
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 Telaprevir and Pegasys®/Copegus® in Patients With Chronic Hepatitis C Genotype 1 Virus Infection Who Were Prior Null Responders to Treatment With Pegylated Interferon/Ribavirin
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 30, 2011 (Actual)
Primary Completion Date
January 31, 2014 (Actual)
Study Completion Date
January 31, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This randomized, double-blind, multi-center, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) (MCB) in combination with telaprevir (TVR) and peginterferon Alfa-2a (PEG-IFN) / ribavirin (RBV) in participants with chronic Hepatitis C infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (24 Weeks)
Arm Type
Experimental
Arm Description
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).
Arm Title
TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (48 Weeks)
Arm Type
Experimental
Arm Description
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).
Arm Title
TVR, MCB, Placebo MCB( each for 12Weeks),PEG-IFN/RBV(48 Weeks)
Arm Type
Experimental
Arm Description
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).
Arm Title
TVR(12 Weeks), Placebo MCB (24 Weeks), PEG-IFN/RBV(48 Weeks)
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Copegus
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Mericitabine
Intervention Description
Participants will receive mericitabine 1000 mg orally twice daily.
Intervention Type
Drug
Intervention Name(s)
Peginterferon Alfa-2a
Other Intervention Name(s)
Pegasys
Intervention Description
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive placebo matching to mericitabine orally twice daily.
Intervention Type
Drug
Intervention Name(s)
Telaprevir
Intervention Description
Participants will receive telaprevir 750 mg orally three times daily.
Primary Outcome Measure Information:
Title
Percent of Participants With Sustained Virological Response 12 Weeks After End of Treatment (SVR12), as Determined by Polymerase Chain Reaction (PCR) Using Roche COBAS TaqMan Hepatitis C Virus (HCV) Test
Time Frame
12 weeks after end of treatment (up to Week 60)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virological Response 4 Weeks After End of Treatment (SVR-4), as Determined by PCR Using Roche COBAS TaqMan HCV Test
Time Frame
4 weeks after end of treatment (up to Week 52)
Title
Percentage of Participants With Sustained Virological Response 24 Weeks After End of Treatment (SVR-24), as Determined by PCR Using Roche COBAS TaqMan HCV Test
Time Frame
24 weeks after end of treatment (up to Week 72)
Title
Percentage of Participants With Virological Response Over Time From Week 2 to Week 48, as Determined by PCR Using Roche COBAS TaqMan HCV Test
Time Frame
Weeks 2, 4, 12, 24, and 48
Title
Percentage of Participants With Treatment- Resistant Mutations, as Determined Using Standard Sequencing Technology
Time Frame
Baseline up to Week 60
Title
Change From Baseline in HCV Ribonucleic Acid (RNA) Levels
Time Frame
Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 30, 36, 42, 48, 52, 60, and 72
Title
Percentage of Participants With Adverse Event
Time Frame
Baseline up to Week 72
Title
Trough Concentration of RO4995855 (Parent Drug of Mericitabine)
Time Frame
Pre-dose (-0.5 hour) on Day 1 and Week 8; 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour post dose in Week 8
Title
Trough Concentration of Metabolite of RO4995855 (RO5012433)
Time Frame
Pre-dose (-0.5 hour) on Day 1 and Week 8; 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour post dose in Week 8
Title
Trough Concentration of Telaprevir
Time Frame
Pre-dose (-0.5 hour) on Day 1 and Week 8; 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour post dose in Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic hepatitis C infection for at least 6 months duration
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:
Hepatitis C infection with a genotype other than genotype 1a or 1b
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Birmingham Gastro Associates, P.C.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
VA Long Beach Healthcare System
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Kaiser Permanente Sacramento Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
UCSD Antiviral Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Gastroenterology Group of Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
John Hopkins Hospital
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
Metrowest Medical Center
City
Framingham
State/Province
Massachusetts
ZIP/Postal Code
01702
Country
United States
Facility Name
Saint Louis University Gastroenterology & Hepatology; Clinical Research Unit
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Carolina'S Center For Liver Disease
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28677
Country
United States
Facility Name
Uni of Cincinnati College of Medicine; Div. of Digestive Diseases
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0595
Country
United States
Facility Name
Baylor Uni Medical Center; Division Of Hepatology/Transplantation; Annette C. and Harold C. Simmons
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
McGuire; Veteran Affairs Med Ctr
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Gordon & Leslie Diamond Health Care Centre; Dept. of Medicine - Division of Gastroenterology
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
GI Research Institute; Gastroenterology & Hepatology
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
Percuro Clinical Research Ltd.
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3P9
Country
Canada
Facility Name
Winnipeg Regional Health Authority; Section of Hepatology
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
University Health Network - Toronto Western Hospital; Hepatology
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1L7
Country
Canada
Facility Name
Toronto Digest. Disease Asso.
City
Woodbridge
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
Facility Name
McGill University, Montreal Chest Institute; Viral and other Infectious
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X2P4
Country
Canada
Facility Name
Hopital Claude Huriez;Gastro Enterologie
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Fondation Hopital Saint Joseph; Gastro-Enterologie
City
Marseille
ZIP/Postal Code
13285
Country
France
Facility Name
Hopital Purpan;Gastro Enterologie Hepatologie
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I
City
Frankfurt Am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Uniklinik Freiburg; Abteilung Innere Medizin II
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitäts Klinikum; Schleswig-Holstein Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Divisione Malattie Infettive
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20162
Country
Italy
Facility Name
Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56124
Country
Italy
Facility Name
Hospital Universitario de Canarias; Servicio de Digestivo
City
La Laguna
State/Province
Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron; Departamento de Enfermedades Infecciosas
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic I Provincial; Servicio de Digestivo
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Carlos III; Laboratorio de Biologia Molecular
City
Madrid
ZIP/Postal Code
28029
Country
Spain
Facility Name
Royal Bournemouth Hospital, Gastroenterology
City
Dorset
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
King'S College Hospital; Institute of Liver Studies
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
St George's Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust; Hepatology Clinical Research Facility
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
26752189
Citation
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.
Results Reference
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A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C
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