A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C
21 april 2017 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
80
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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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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Alabama
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Birmingham, Alabama, Förenta staterna, 35209
- Birmingham Gastro Associates, P.C.
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California
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Long Beach, California, Förenta staterna, 90822
- VA Long Beach Healthcare System
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Sacramento, California, Förenta staterna, 95825
- Kaiser Permanente Sacramento Medical Center
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San Diego, California, Förenta staterna, 92103
- UCSD Antiviral Research Center
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Connecticut
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New Haven, Connecticut, Förenta staterna, 06510
- Yale University
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Florida
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Naples, Florida, Förenta staterna, 34102
- Gastroenterology Group of Naples
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Maryland
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Lutherville, Maryland, Förenta staterna, 21093
- John Hopkins Hospital
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Massachusetts
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Framingham, Massachusetts, Förenta staterna, 01702
- MetroWest Medical Center
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Missouri
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Saint Louis, Missouri, Förenta staterna, 63104
- Saint Louis University Gastroenterology & Hepatology; Clinical Research Unit
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New York
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New York, New York, Förenta staterna, 10021
- Weill Cornell Medical College
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North Carolina
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Statesville, North Carolina, Förenta staterna, 28677
- Carolina'S Center For Liver Disease
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45267-0595
- Uni of Cincinnati College of Medicine; Div. of Digestive Diseases
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Texas
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Dallas, Texas, Förenta staterna, 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, Förenta staterna, 23249
- McGuire; Veteran Affairs Med Ctr
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Washington
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Seattle, Washington, Förenta staterna, 98104
- Harborview Medical Center
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Emilia-Romagna
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Bologna, Emilia-Romagna, Italien, 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, Italien, 20162
- ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Divisione Malattie Infettive
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Toscana
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Pisa, Toscana, Italien, 56124
- Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia
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British Columbia
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Vancouver, British Columbia, Kanada, V5Z 1M9
- Gordon & Leslie Diamond Health Care Centre; Dept. of Medicine - Division of Gastroenterology
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Vancouver, British Columbia, Kanada, V6Z 2K5
- GI Research Institute; Gastroenterology & Hepatology
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Victoria, British Columbia, Kanada, V8V 3P9
- PerCuro Clinical Research Ltd.
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Manitoba
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Winnipeg, Manitoba, Kanada, R3A 1R9
- Winnipeg Regional Health Authority; Section of Hepatology
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Ontario
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Toronto, Ontario, Kanada, M5G 1L7
- University Health Network - Toronto Western Hospital; Hepatology
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Woodbridge, Ontario, Kanada, L4L 4Y7
- Toronto Digest. Disease Asso.
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Quebec
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Montreal, Quebec, Kanada, H2X2P4
- McGill University, Montreal Chest Institute; Viral and other Infectious
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Barcelona, Spanien, 08035
- Hospital Universitari Vall d'Hebron; Departamento de Enfermedades Infecciosas
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Barcelona, Spanien, 08036
- Hospital Clinic I Provincial; Servicio de Digestivo
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Madrid, Spanien, 28029
- Hospital Carlos III; Laboratorio de Biologia Molecular
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Tenerife
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La Laguna, Tenerife, Spanien, 38320
- Hospital Universitario de Canarias; Servicio de Digestivo
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Dorset, Storbritannien, BH7 7DW
- Royal Bournemouth Hospital, Gastroenterology
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London, Storbritannien, SW17 0QT
- St George's Hospital
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London, Storbritannien, SE5 9RS
- King'S College Hospital; Institute of Liver Studies
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London, Storbritannien, 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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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
Andra namn:
Participants will receive mericitabine 1000 mg orally twice daily.
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
Andra namn:
Participants will receive telaprevir 750 mg orally three times daily.
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Experimentell: 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.
Andra namn:
Participants will receive mericitabine 1000 mg orally twice daily.
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
Andra namn:
Participants will receive telaprevir 750 mg orally three times daily.
|
|
Experimentell: 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.
Andra namn:
Participants will receive mericitabine 1000 mg orally twice daily.
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
Andra namn:
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.
Andra namn:
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
Andra namn:
Participants will receive telaprevir 750 mg orally three times daily.
Participants will receive placebo matching to mericitabine orally twice daily.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
30 november 2011
Primärt slutförande (Faktisk)
31 januari 2014
Avslutad studie (Faktisk)
31 januari 2014
Studieregistreringsdatum
Först inskickad
28 november 2011
Först inskickad som uppfyllde QC-kriterierna
28 november 2011
Första postat (Uppskatta)
30 november 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 april 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 april 2017
Senast verifierad
1 april 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- RNA-virusinfektioner
- Virussjukdomar
- Infektioner
- Blodburna infektioner
- Smittsamma sjukdomar
- Leversjukdomar
- Flaviviridae-infektioner
- Hepatit, Viral, Human
- Enterovirusinfektioner
- Picornaviridae-infektioner
- Hepatit, kronisk
- Hepatit
- Hepatit A
- Hepatit C
- Hepatit C, kronisk
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Antimetaboliter
- Ribavirin
- Peginterferon alfa-2a
Andra studie-ID-nummer
- NV27779
- 2011-002715-28 (EudraCT-nummer)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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