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- Klinische proef NCT01718145
A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV Subjects
A Phase 3, Comparative Study of Asunaprevir and Daclatasvir (DUAL) Combination Therapy Versus Telaprevir Therapy in Japanese Genotype 1b Chronic Hepatitis C IFN Eligible-naive Subjects With a Single Arm Assessment of DUAL Therapy in IFN-therapy Relapsers
The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subject.
The purpose of this study is to compare the anti-viral activity of the co-administration of Asunaprevir (ASV) and Daclatasvir (DCV) to Telaprevir (TVR) included therapy in Japanese Hepatitis C virus (HCV) subjects
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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Fukui, Japan, 9188503
- Local Institution
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Fukuoka, Japan, 8158555
- Local Institution
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Fukuoka, Japan, 8140180
- Local Institution
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Gifu, Japan, 5008513
- Local Institution
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Kumamoto, Japan, 8628655
- Local Institution
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Nagoya-shi, Japan, 4678602
- Local Institution
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Nishinomiya-shi, Japan, 6638501
- Local Institution
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Osaka, Japan, 5400006
- Local Institution
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Saitama, Japan, 3380001
- Local Institution
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Aichi
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Nagoya-shi, Aichi, Japan, 4668560
- Local Institution
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Toyoake Shi, Aichi, Japan, 4701192
- Local Institution
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Chiba
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Chiba-shi, Chiba, Japan, 2608677
- Local Institution
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Fukuoka
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Fukuoka-shi, Fukuoka, Japan, 8108563
- Local Institution
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Kurume, Fukuoka, Japan, 8300011
- Local Institution
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Gifu
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Ogaki-shi, Gifu, Japan, 5038502
- Local Institution
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Gunma
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Takasaki City, Gunma, Japan, 3700829
- Local Institution
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Hiroshima
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Hiroshima-shi, Hiroshima, Japan, 7340037
- Local Institution
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Hokkaido
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Obihiro-shi, Hokkaido, Japan, 080-0016
- Local Institution
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Sapporo-shi, Hokkaido, Japan, 0600033
- Local Institution
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Sapporo-shi, Hokkaido, Japan, 0608648
- Local Institution
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Kagawa
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Takamatsu-shi, Kagawa, Japan, 760-8557
- Local Institution
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Kagoshima
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Kagoshima-shi, Kagoshima, Japan, 8908520
- Local Institution
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Kanagawa
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Kawasaki-shi, Kanagawa, Japan, 2138587
- Local Institution
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Yokohama-shi, Kanagawa, Japan, 2360004
- Local Institution
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Kumamoto
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Kumamoto-shi, Kumamoto, Japan, 8608556
- Local Institution
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Kyoto
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Kyoto-shi, Kyoto, Japan, 6028566
- Local Institution
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Miyagi
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Sendai-shi, Miyagi, Japan, 9808574
- Local Institution
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Nagano
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Matsumoto, Nagano, Japan, 3908621
- Local Institution
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Nagasaki
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Nagasaki-shi, Nagasaki, Japan, 8528501
- Local Institution
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Omura, Nagasaki, Japan, 8568562
- Local Institution
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Nara
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Kashihara, Nara, Japan, 6348522
- Local Institution
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Oita
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Yufu, Oita, Japan, 8795593
- Local Institution
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Okayama
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Okayama-shi, Okayama, Japan, 7008558
- Local Institution
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Osaka
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Osaka-sayama-shi, Osaka, Japan, 5898511
- Local Institution
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Osaka-shi, Osaka, Japan, 5438555
- Local Institution
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Osaka-shi, Osaka, Japan, 5458586
- Local Institution
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Suita, Osaka, Japan, 5640013
- Local Institution
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Suita-shi, Osaka, Japan, 5650871
- Local Institution
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Saitama
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Iruma-gun, Saitama, Japan, 3500495
- Local Institution
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Shizuoka
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Izunokuni, Shizuoka, Japan, 4102295
- Local Institution
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Tochigi
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Shimotsuke-shi, Tochigi, Japan, 3290498
- Local Institution
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Tokyo
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Bunkyo-ku, Tokyo, Japan, 1138655
- Local Institution
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Bunkyo-ku, Tokyo, Japan, 1138519
- Local Institution
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Minato-ku, Tokyo, Japan, 1058470
- Local Institution
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Musashino-shi, Tokyo, Japan, 1808610
- Local Institution
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Shinagawa-ku, Tokyo, Japan, 1428666
- Local Institution
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Yamagata
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Yamagata-shi, Yamagata, Japan, 9909585
- Local Institution
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Yamanashi
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Chuo-shi, Yamanashi, Japan, 4093898
- Local Institution
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Chronic HCV-1b infected patient
- HCV Ribonucleic acid (RNA) > 100,000 IU/mL at screening
- Ages 20 to 70 years (for the Naive cohort), ages 20 to 75 years (for the Relapser cohort)
- Treatment naive subjects to Interferon (IFN) based therapy
- Subjects who had undetectable HCV RNA at end of treatment with prior exposure to an IFN-containing regimen, but HCV RNA detectable within 24 weeks of treatment follow-up
Exclusion Criteria:
Patients who have;
- Hepatocellular carcinoma
- Co-infection with Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV)
- Severe or uncontrollable complication
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Arm 1: Daclatasvir + Asunaprevir
Daclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks - Naive cohort |
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Actieve vergelijker: Arm 2: Telaprevir + pegIFNα-2b + Ribavirin
Telaprevir 750 mg tablets by mouth three times daily, pegIFNα-2b 1.5 μg/kg solution by Subcutaneous weekly & Ribavirin 600- 1000 mg Capsules by mouth twice daily for 24 Weeks - Naive cohort |
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Experimenteel: Arm 3: Daclatasvir + Asunaprevir
Daclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks - Relapser cohort |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the naive cohort
Tijdsspanne: After 12 weeks of the last dose
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After 12 weeks of the last dose
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Proportion of subjects with hemoglobin < 10g/dL
Tijdsspanne: First 12 weeks of treatment
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First 12 weeks of treatment
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Proportion of subjects with rash-related dermatologic events
Tijdsspanne: First 12 weeks of treatment
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First 12 weeks of treatment
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Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the naive cohort
Tijdsspanne: At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12; EOT (up to 24 weeks), post-treatment Week 4 and post-treatment Week 24
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EOT = End of treatment
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At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12; EOT (up to 24 weeks), post-treatment Week 4 and post-treatment Week 24
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Proportion of subjects with HCV RNA target not detected in the naive cohort
Tijdsspanne: At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 4, post-treatment Week 12 and post-treatment Week 24
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eRVR = Extended rapid virologic response
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At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 4, post-treatment Week 12 and post-treatment Week 24
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Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the relapser cohort
Tijdsspanne: At post-treatment Week 12
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At post-treatment Week 12
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Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the relapser cohort
Tijdsspanne: At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12; EOT (up to 24 weeks), post-treatment Week 4 and Week 24
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At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12; EOT (up to 24 weeks), post-treatment Week 4 and Week 24
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Proportion of subjects with HCV RNA target not detected in the relapser cohort
Tijdsspanne: At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 4, post-treatment Week 12 and post-treatment Week 24
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At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 4, post-treatment Week 12 and post-treatment Week 24
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On treatment safety, as measured by the frequency of Severe adverse events (SAEs), discontinuation and dose modification/interruption due to Adverse events (AEs), Grade 3-4 abnormalities observed from clinical laboratory tests for each treatment group
Tijdsspanne: End of treatment (24 weeks) plus 7days
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End of treatment (24 weeks) plus 7days
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- RNA-virusinfecties
- Virusziekten
- Infecties
- Door bloed overgedragen infecties
- Overdraagbare ziekten
- Lever Ziekten
- Flaviviridae-infecties
- Hepatitis, viraal, menselijk
- Hepatitis
- Hepatitis C
- Moleculaire mechanismen van farmacologische werking
- Anti-infectieuze middelen
- Antivirale middelen
- Enzymremmers
- Antimetabolieten
- Proteaseremmers
- Ribavirine
- Asunaprevir
Andere studie-ID-nummers
- AI447-031
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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