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A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV Subjects

23. september 2015 oppdatert av: Bristol-Myers Squibb

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

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Intervention Model: Parallel in the Naive cohort and Single group in the Relapser cohort

Studietype

Intervensjonell

Registrering (Faktiske)

258

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Japan
      • Fukui, Japan, 9188503
        • Local Institution
      • Fukuoka, Japan, 8158555
        • Local Institution
      • Fukuoka, Japan, 8140180
        • Local Institution
      • Gifu, Japan, 5008513
        • Local Institution
      • Kumamoto, Japan, 8628655
        • Local Institution
      • Nagoya-shi, Japan, 4678602
        • Local Institution
      • Nishinomiya-shi, Japan, 6638501
        • Local Institution
      • Osaka, Japan, 5400006
        • Local Institution
      • Saitama, Japan, 3380001
        • Local Institution
    • Aichi
      • Nagoya-shi, Aichi, Japan, 4668560
        • Local Institution
      • Toyoake Shi, Aichi, Japan, 4701192
        • Local Institution
    • Chiba
      • Chiba-shi, Chiba, Japan, 2608677
        • Local Institution
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 8108563
        • Local Institution
      • Kurume, Fukuoka, Japan, 8300011
        • Local Institution
    • Gifu
      • Ogaki-shi, Gifu, Japan, 5038502
        • Local Institution
    • Gunma
      • Takasaki City, Gunma, Japan, 3700829
        • Local Institution
    • Hiroshima
      • Hiroshima-shi, Hiroshima, Japan, 7340037
        • Local Institution
    • Hokkaido
      • Obihiro-shi, Hokkaido, Japan, 080-0016
        • Local Institution
      • Sapporo-shi, Hokkaido, Japan, 0600033
        • Local Institution
      • Sapporo-shi, Hokkaido, Japan, 0608648
        • Local Institution
    • Kagawa
      • Takamatsu-shi, Kagawa, Japan, 760-8557
        • Local Institution
    • Kagoshima
      • Kagoshima-shi, Kagoshima, Japan, 8908520
        • Local Institution
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan, 2138587
        • Local Institution
      • Yokohama-shi, Kanagawa, Japan, 2360004
        • Local Institution
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan, 8608556
        • Local Institution
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 6028566
        • Local Institution
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 9808574
        • Local Institution
    • Nagano
      • Matsumoto, Nagano, Japan, 3908621
        • Local Institution
    • Nagasaki
      • Nagasaki-shi, Nagasaki, Japan, 8528501
        • Local Institution
      • Omura, Nagasaki, Japan, 8568562
        • Local Institution
    • Nara
      • Kashihara, Nara, Japan, 6348522
        • Local Institution
    • Oita
      • Yufu, Oita, Japan, 8795593
        • Local Institution
    • Okayama
      • Okayama-shi, Okayama, Japan, 7008558
        • Local Institution
    • Osaka
      • Osaka-sayama-shi, Osaka, Japan, 5898511
        • Local Institution
      • Osaka-shi, Osaka, Japan, 5438555
        • Local Institution
      • Osaka-shi, Osaka, Japan, 5458586
        • Local Institution
      • Suita, Osaka, Japan, 5640013
        • Local Institution
      • Suita-shi, Osaka, Japan, 5650871
        • Local Institution
    • Saitama
      • Iruma-gun, Saitama, Japan, 3500495
        • Local Institution
    • Shizuoka
      • Izunokuni, Shizuoka, Japan, 4102295
        • Local Institution
    • Tochigi
      • Shimotsuke-shi, Tochigi, Japan, 3290498
        • Local Institution
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 1138655
        • Local Institution
      • Bunkyo-ku, Tokyo, Japan, 1138519
        • Local Institution
      • Minato-ku, Tokyo, Japan, 1058470
        • Local Institution
      • Musashino-shi, Tokyo, Japan, 1808610
        • Local Institution
      • Shinagawa-ku, Tokyo, Japan, 1428666
        • Local Institution
    • Yamagata
      • Yamagata-shi, Yamagata, Japan, 9909585
        • Local Institution
    • Yamanashi
      • Chuo-shi, Yamanashi, Japan, 4093898
        • Local Institution

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

20 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

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: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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
Legemiddel: Daclatasvir
Legemiddel: Asunaprevir
Aktiv komparator: 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
Legemiddel: Ribavirin
Legemiddel: Telaprevir
Biologisk: pegIFNα-2b
Eksperimentell: 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
Legemiddel: Daclatasvir
Legemiddel: Asunaprevir

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the naive cohort
Tidsramme: After 12 weeks of the last dose
  • SVR12 = Sustained virologic response at post-treatment Week 12
  • LLOQ = Lower Limit of quantitation
After 12 weeks of the last dose

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of subjects with hemoglobin < 10g/dL
Tidsramme: First 12 weeks of treatment
First 12 weeks of treatment
Proportion of subjects with rash-related dermatologic events
Tidsramme: First 12 weeks of treatment
First 12 weeks of treatment
Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the naive cohort
Tidsramme: 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
EOT = End of treatment
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
Proportion of subjects with HCV RNA target not detected in the naive cohort
Tidsramme: 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
eRVR = Extended rapid virologic response
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
Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the relapser cohort
Tidsramme: At post-treatment Week 12
At post-treatment Week 12
Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the relapser cohort
Tidsramme: 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
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
Proportion of subjects with HCV RNA target not detected in the relapser cohort
Tidsramme: 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
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
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
Tidsramme: End of treatment (24 weeks) plus 7days
End of treatment (24 weeks) plus 7days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Bristol-Myers Squibb

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.

Hjelpsomme linker

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

1. november 2012

Primær fullføring (Faktiske)

1. desember 2013

Studiet fullført (Faktiske)

1. desember 2014

Datoer for studieregistrering

Først innsendt

29. oktober 2012

Først innsendt som oppfylte QC-kriteriene

29. oktober 2012

Først lagt ut (Anslag)

31. oktober 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

9. oktober 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. september 2015

Sist bekreftet

1. september 2015

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AI447-031

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