A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C
21. april 2017 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
80
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Gordon & Leslie Diamond Health Care Centre; Dept. of Medicine - Division of Gastroenterology
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Vancouver, British Columbia, Canada, V6Z 2K5
- GI Research Institute; Gastroenterology & Hepatology
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Victoria, British Columbia, Canada, V8V 3P9
- PerCuro Clinical Research Ltd.
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Manitoba
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Winnipeg, Manitoba, Canada, R3A 1R9
- Winnipeg Regional Health Authority; Section of Hepatology
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Ontario
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Toronto, Ontario, Canada, M5G 1L7
- University Health Network - Toronto Western Hospital; Hepatology
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Woodbridge, Ontario, Canada, L4L 4Y7
- Toronto Digest. Disease Asso.
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Quebec
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Montreal, Quebec, Canada, H2X2P4
- McGill University, Montreal Chest Institute; Viral and other Infectious
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Alabama
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Birmingham, Alabama, Forente stater, 35209
- Birmingham Gastro Associates, P.C.
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California
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Long Beach, California, Forente stater, 90822
- VA Long Beach Healthcare System
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Sacramento, California, Forente stater, 95825
- Kaiser Permanente Sacramento Medical Center
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San Diego, California, Forente stater, 92103
- UCSD Antiviral Research Center
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Connecticut
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New Haven, Connecticut, Forente stater, 06510
- Yale University
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Florida
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Naples, Florida, Forente stater, 34102
- Gastroenterology Group of Naples
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Maryland
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Lutherville, Maryland, Forente stater, 21093
- John Hopkins Hospital
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Massachusetts
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Framingham, Massachusetts, Forente stater, 01702
- MetroWest Medical Center
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Missouri
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Saint Louis, Missouri, Forente stater, 63104
- Saint Louis University Gastroenterology & Hepatology; Clinical Research Unit
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New York
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New York, New York, Forente stater, 10021
- Weill Cornell Medical College
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North Carolina
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Statesville, North Carolina, Forente stater, 28677
- Carolina'S Center For Liver Disease
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Ohio
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Cincinnati, Ohio, Forente stater, 45267-0595
- Uni of Cincinnati College of Medicine; Div. of Digestive Diseases
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Texas
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Dallas, Texas, Forente stater, 75246
- Baylor Uni Medical Center; Division Of Hepatology/Transplantation; Annette C. and Harold C. Simmons
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Virginia
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Richmond, Virginia, Forente stater, 23249
- McGuire; Veteran Affairs Med Ctr
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Washington
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Seattle, Washington, Forente stater, 98104
- Harborview Medical Center
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Lille, Frankrike, 59037
- Hopital Claude Huriez;Gastro Enterologie
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Marseille, Frankrike, 13285
- Fondation Hopital Saint Joseph; Gastro-Enterologie
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Toulouse, Frankrike, 31059
- Hopital Purpan;Gastro Enterologie Hepatologie
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Emilia-Romagna
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Bologna, Emilia-Romagna, Italia, 40138
- UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In
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Lombardia
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Milano, Lombardia, Italia, 20162
- ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Divisione Malattie Infettive
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Toscana
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Pisa, Toscana, Italia, 56124
- Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia
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Barcelona, Spania, 08035
- Hospital Universitari Vall d'Hebron; Departamento de Enfermedades Infecciosas
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Barcelona, Spania, 08036
- Hospital Clinic I Provincial; Servicio de Digestivo
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Madrid, Spania, 28029
- Hospital Carlos III; Laboratorio de Biologia Molecular
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Tenerife
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La Laguna, Tenerife, Spania, 38320
- Hospital Universitario de Canarias; Servicio de Digestivo
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Dorset, Storbritannia, BH7 7DW
- Royal Bournemouth Hospital, Gastroenterology
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London, Storbritannia, SW17 0QT
- St George's Hospital
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London, Storbritannia, SE5 9RS
- King'S College Hospital; Institute of Liver Studies
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London, Storbritannia, W2 1NY
- Imperial College Healthcare NHS Trust; Hepatology Clinical Research Facility
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Frankfurt Am Main, Tyskland, 60590
- Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I
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Freiburg, Tyskland, 79106
- Uniklinik Freiburg; Abteilung Innere Medizin II
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Kiel, Tyskland, 24105
- Universitäts Klinikum; Schleswig-Holstein Kiel
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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).
|
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 navn:
Participants will receive mericitabine 1000 mg orally twice daily.
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
Andre navn:
Participants will receive telaprevir 750 mg orally three times daily.
|
|
Eksperimentell: 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).
|
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 navn:
Participants will receive mericitabine 1000 mg orally twice daily.
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
Andre navn:
Participants will receive telaprevir 750 mg orally three times daily.
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Eksperimentell: 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).
|
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 navn:
Participants will receive mericitabine 1000 mg orally twice daily.
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
Andre navn:
Participants will receive telaprevir 750 mg orally three times daily.
Participants will receive placebo matching to mericitabine orally twice daily.
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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).
|
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 navn:
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
Andre navn:
Participants will receive telaprevir 750 mg orally three times daily.
Participants will receive placebo matching to mericitabine orally twice daily.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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)
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12 weeks after end of treatment (up to Week 60)
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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)
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4 weeks after end of treatment (up to Week 52)
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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)
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24 weeks after end of treatment (up to Week 72)
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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
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Weeks 2, 4, 12, 24, and 48
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Percentage of Participants With Treatment- Resistant Mutations, as Determined Using Standard Sequencing Technology
Tidsramme: Baseline up to Week 60
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Baseline up to Week 60
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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
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Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 30, 36, 42, 48, 52, 60, and 72
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Percentage of Participants With Adverse Event
Tidsramme: Baseline up to Week 72
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Baseline up to Week 72
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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
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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
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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
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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
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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
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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
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
30. november 2011
Primær fullføring (Faktiske)
31. januar 2014
Studiet fullført (Faktiske)
31. januar 2014
Datoer for studieregistrering
Først innsendt
28. november 2011
Først innsendt som oppfylte QC-kriteriene
28. november 2011
Først lagt ut (Anslag)
30. november 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. april 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. april 2017
Sist bekreftet
1. april 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Leversykdommer
- Flaviviridae-infeksjoner
- Hepatitt, viral, menneskelig
- Enterovirusinfeksjoner
- Picornaviridae-infeksjoner
- Hepatitt, kronisk
- Hepatitt
- Hepatitt A-virus
- Hepatitt C
- Hepatitt C, kronisk
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Antimetabolitter
- Ribavirin
- Peginterferon alfa-2a
Andre studie-ID-numre
- NV27779
- 2011-002715-28 (EudraCT-nummer)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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