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A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT01482390
Collaborator
(none)
80
Enrollment
39
Locations
4
Arms
26.1
Actual Duration (Months)
2.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 30, 2011
Actual Primary Completion Date :
Jan 31, 2014
Actual Study Completion Date :
Jan 31, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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).

Drug: 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.
Other Names:
  • Copegus

    • Drug: Mericitabine
    Participants will receive mericitabine 1000 mg orally twice daily.

    Drug: Peginterferon Alfa-2a
    Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
    Other Names:
  • Pegasys

    • Drug: Telaprevir
    Participants will receive telaprevir 750 mg orally three times daily.
    Experimental: 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).

    Drug: 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.
    Other Names:
  • Copegus

    • Drug: Mericitabine
    Participants will receive mericitabine 1000 mg orally twice daily.

    Drug: Peginterferon Alfa-2a
    Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
    Other Names:
  • Pegasys

    • Drug: Telaprevir
    Participants will receive telaprevir 750 mg orally three times daily.
    Experimental: 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).

    Drug: 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.
    Other Names:
  • Copegus

    • Drug: Mericitabine
    Participants will receive mericitabine 1000 mg orally twice daily.

    Drug: Peginterferon Alfa-2a
    Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
    Other Names:
  • Pegasys

    • Drug: Placebo
    Participants will receive placebo matching to mericitabine orally twice daily.

    Drug: Telaprevir
    Participants will receive telaprevir 750 mg orally three times daily.
    Active Comparator: 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).

    Drug: 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.
    Other Names:
  • Copegus

    • Drug: Peginterferon Alfa-2a
    Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
    Other Names:
  • Pegasys

    • Drug: Placebo
    Participants will receive placebo matching to mericitabine orally twice daily.

    Drug: Telaprevir
    Participants will receive telaprevir 750 mg orally three times daily.

    Outcome Measures

    Primary Outcome Measures

    1. 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 [12 weeks after end of treatment (up to Week 60)]

    Secondary Outcome Measures

    1. 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 [4 weeks after end of treatment (up to Week 52)]

    2. 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 [24 weeks after end of treatment (up to Week 72)]

    3. Percentage of Participants With Virological Response Over Time From Week 2 to Week 48, as Determined by PCR Using Roche COBAS TaqMan HCV Test [Weeks 2, 4, 12, 24, and 48]

    4. Percentage of Participants With Treatment- Resistant Mutations, as Determined Using Standard Sequencing Technology [Baseline up to Week 60]

    5. Change From Baseline in HCV Ribonucleic Acid (RNA) Levels [Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 30, 36, 42, 48, 52, 60, and 72]

    6. Percentage of Participants With Adverse Event [Baseline up to Week 72]

    7. Trough Concentration of RO4995855 (Parent Drug of Mericitabine) [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]

    8. Trough Concentration of Metabolite of RO4995855 (RO5012433) [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]

    9. Trough Concentration of Telaprevir [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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Gastro Associates, P.C. Birmingham Alabama United States 35209
    2 VA Long Beach Healthcare System Long Beach California United States 90822
    3 Kaiser Permanente Sacramento Medical Center Sacramento California United States 95825
    4 UCSD Antiviral Research Center San Diego California United States 92103
    5 Yale University New Haven Connecticut United States 06510
    6 Gastroenterology Group of Naples Naples Florida United States 34102
    7 John Hopkins Hospital Lutherville Maryland United States 21093
    8 Metrowest Medical Center Framingham Massachusetts United States 01702
    9 Saint Louis University Gastroenterology & Hepatology; Clinical Research Unit Saint Louis Missouri United States 63104
    10 Weill Cornell Medical College New York New York United States 10021
    11 Carolina'S Center For Liver Disease Statesville North Carolina United States 28677
    12 Uni of Cincinnati College of Medicine; Div. of Digestive Diseases Cincinnati Ohio United States 45267-0595
    13 Baylor Uni Medical Center; Division Of Hepatology/Transplantation; Annette C. and Harold C. Simmons Dallas Texas United States 75246
    14 McGuire; Veteran Affairs Med Ctr Richmond Virginia United States 23249
    15 Harborview Medical Center Seattle Washington United States 98104
    16 Gordon & Leslie Diamond Health Care Centre; Dept. of Medicine - Division of Gastroenterology Vancouver British Columbia Canada V5Z 1M9
    17 GI Research Institute; Gastroenterology & Hepatology Vancouver British Columbia Canada V6Z 2K5
    18 Percuro Clinical Research Ltd. Victoria British Columbia Canada V8V 3P9
    19 Winnipeg Regional Health Authority; Section of Hepatology Winnipeg Manitoba Canada R3A 1R9
    20 University Health Network - Toronto Western Hospital; Hepatology Toronto Ontario Canada M5G 1L7
    21 Toronto Digest. Disease Asso. Woodbridge Ontario Canada L4L 4Y7
    22 McGill University, Montreal Chest Institute; Viral and other Infectious Montreal Quebec Canada H2X2P4
    23 Hopital Claude Huriez;Gastro Enterologie Lille France 59037
    24 Fondation Hopital Saint Joseph; Gastro-Enterologie Marseille France 13285
    25 Hopital Purpan;Gastro Enterologie Hepatologie Toulouse France 31059
    26 Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I Frankfurt Am Main Germany 60590
    27 Uniklinik Freiburg; Abteilung Innere Medizin II Freiburg Germany 79106
    28 Universitäts Klinikum; Schleswig-Holstein Kiel Kiel Germany 24105
    29 UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In Bologna Emilia-Romagna Italy 40138
    30 ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Divisione Malattie Infettive Milano Lombardia Italy 20162
    31 Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia Pisa Toscana Italy 56124
    32 Hospital Universitario de Canarias; Servicio de Digestivo La Laguna Tenerife Spain 38320
    33 Hospital Universitari Vall d'Hebron; Departamento de Enfermedades Infecciosas Barcelona Spain 08035
    34 Hospital Clinic I Provincial; Servicio de Digestivo Barcelona Spain 08036
    35 Hospital Carlos III; Laboratorio de Biologia Molecular Madrid Spain 28029
    36 Royal Bournemouth Hospital, Gastroenterology Dorset United Kingdom BH7 7DW
    37 King'S College Hospital; Institute of Liver Studies London United Kingdom SE5 9RS
    38 St George's Hospital London United Kingdom SW17 0QT
    39 Imperial College Healthcare NHS Trust; Hepatology Clinical Research Facility London United Kingdom W2 1NY

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT01482390
    Other Study ID Numbers:
    • NV27779
    • 2011-002715-28
    First Posted:
    Nov 30, 2011
    Last Update Posted:
    Apr 24, 2017
    Last Verified:
    Apr 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis C
    Hepatitis C, Chronic
    Hepatitis
    Ribavirin
    Peginterferon alfa-2a

    Study Results

    No Results Posted as of Apr 24, 2017