Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

21. april 2017 opdateret af: Hoffmann-La Roche

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

80

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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).
Medicin: 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.
Andre navne:
  • Copegus
Medicin: Mericitabine
Participants will receive mericitabine 1000 mg orally twice daily.
Medicin: Peginterferon Alfa-2a
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
Andre navne:
  • Pegasys
Medicin: Telaprevir
Participants will receive telaprevir 750 mg orally three times daily.
Eksperimentel: 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).
Medicin: 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.
Andre navne:
  • Copegus
Medicin: Mericitabine
Participants will receive mericitabine 1000 mg orally twice daily.
Medicin: Peginterferon Alfa-2a
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
Andre navne:
  • Pegasys
Medicin: Telaprevir
Participants will receive telaprevir 750 mg orally three times daily.
Eksperimentel: 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).
Medicin: 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.
Andre navne:
  • Copegus
Medicin: Mericitabine
Participants will receive mericitabine 1000 mg orally twice daily.
Medicin: Peginterferon Alfa-2a
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
Andre navne:
  • Pegasys
Medicin: Telaprevir
Participants will receive telaprevir 750 mg orally three times daily.
Medicin: Placebo
Participants will receive placebo matching to mericitabine orally twice daily.
Aktiv komparator: 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).
Medicin: 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.
Andre navne:
  • Copegus
Medicin: Peginterferon Alfa-2a
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
Andre navne:
  • Pegasys
Medicin: Telaprevir
Participants will receive telaprevir 750 mg orally three times daily.
Medicin: Placebo
Participants will receive placebo matching to mericitabine orally twice daily.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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
Tidsramme: 12 weeks after end of treatment (up to Week 60)
12 weeks after end of treatment (up to Week 60)

Sekundære resultatmål

Resultatmål
Tidsramme
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
Tidsramme: 4 weeks after end of treatment (up to Week 52)
4 weeks after end of treatment (up to Week 52)
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
Tidsramme: 24 weeks after end of treatment (up to Week 72)
24 weeks after end of treatment (up to Week 72)
Percentage of Participants With Virological Response Over Time From Week 2 to Week 48, as Determined by PCR Using Roche COBAS TaqMan HCV Test
Tidsramme: Weeks 2, 4, 12, 24, and 48
Weeks 2, 4, 12, 24, and 48
Percentage of Participants With Treatment- Resistant Mutations, as Determined Using Standard Sequencing Technology
Tidsramme: Baseline up to Week 60
Baseline up to Week 60
Change From Baseline in HCV Ribonucleic Acid (RNA) Levels
Tidsramme: Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 30, 36, 42, 48, 52, 60, and 72
Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 30, 36, 42, 48, 52, 60, and 72
Percentage of Participants With Adverse Event
Tidsramme: Baseline up to Week 72
Baseline up to Week 72
Trough Concentration of RO4995855 (Parent Drug of Mericitabine)
Tidsramme: 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
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
Trough Concentration of Metabolite of RO4995855 (RO5012433)
Tidsramme: 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
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
Trough Concentration of Telaprevir
Tidsramme: 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
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. november 2011

Primær færdiggørelse (Faktiske)

31. januar 2014

Studieafslutning (Faktiske)

31. januar 2014

Datoer for studieregistrering

Først indsendt

28. november 2011

Først indsendt, der opfyldte QC-kriterier

28. november 2011

Først opslået (Skøn)

30. november 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NV27779
  • 2011-002715-28 (EudraCT nummer)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hepatitis C

Kliniske forsøg med Ribavirin

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Ireland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner