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An Open-Label Rollover Study of Entecavir (BMS-200475) in Adults With Chronic Hepatitis B Infection

24. januar 2011 opdateret af: Bristol-Myers Squibb

An Open-Label Rollover Study of Entecavir (BMS-200475) in Adults With Chronic Hepatitis B Infection Who Have Completed Previous Phase II Studies in Japan But Who Require Further Treatment

To provide open-label entecavir to subjects who have completed previous blinded entecavir trials in Japan and are assessed by the investigator as likely to benefit from additional anti-hepatitis B therapy

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

282

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Japan
      • Kyoto, Japan
        • Local Institution
      • Niigata, Japan
        • Local Institution
      • Osaka, Japan
        • Local Institution
      • Tokyo, Japan, 173-8610
        • Local Institution
    • Aichi
      • Aichi-Gun, Aichi, Japan, 480-1195
        • Local Institution
      • Nagoya, Aichi, Japan, 466-8550
        • Local Institution
      • Nagoya-Shi, Aichi, Japan, 467-8602
        • Local Institution
      • Nagoya-Shi, Aichi, Japan, 457-0866
        • Local Institution
    • Chiba
      • Chiba-Shi, Chiba, Japan
        • Local Institution
    • Ehime
      • Onsen-Gun, Ehime, Japan, 791-0204
        • Local Institution
    • Fukuoka
      • Fukuoka-Shi, Fukuoka, Japan, 814-0180
        • Local Institution
      • Kurume, Fukuoka, Japan
        • Local Institution
    • Gifu
      • Gifu-Shi, Gifu, Japan, 500-8513
        • Local Institution
      • Ogaki-Shi, Gifu, Japan, 503-8502
        • Local Institution
    • Hiroshima
      • Fukuyama-Shi, Hiroshima, Japan, 721-0971
        • Local Institution
      • Hiroshima City, Hiroshima, Japan, 734-0037
        • Local Institution
      • Hiroshima-Shi, Hiroshima, Japan, 730-8518
        • Local Institution
    • Hokkaido
      • Asahikawa-Shi, Hokkaido, Japan, 070-0054
        • Local Institution
      • Sapporo-Shi, Hokkaido, Japan, 060-0033
        • Local Institution
      • Sapporo-Shi, Hokkaido, Japan, 006-0813
        • Local Institution
    • Hyogo
      • Akashi-Shi, Hyogo, Japan, 673-0848
        • Local Institution
    • Iwate
      • Morioka-Shi, Iwate, Japan, 020-8505
        • Local Institution
    • Kagawa
      • Mitoyo-Gun, Kagawa, Japan, 769-1601
        • Local Institution
      • Takamatsu-City, Kagawa, Japan
        • Local Institution
    • Kumamoto
      • Kumamoto-Shi, Kumamoto, Japan, 860-8556
        • Local Institution
    • Miyagi
      • Sendai, Miyagi, Japan
        • Local Institution
    • Miyazaki
      • Miyazaki-Gun, Miyazaki, Japan, 889-1692
        • Local Institution
    • Nagano
      • Matsumoto City, Nagano, Japan, 390-0802
        • Local Institution
    • Nagasaki
      • Nagasaki City, Nagasaki, Japan
        • Local Institution
      • Omura-Shi, Nagasaki, Japan, 856-0000
        • Local Institution
    • Oita
      • Oita-Gun, Oita, Japan, 879-5503
        • Local Institution
    • Okayama
      • Kurashiki-Shi, Okayama, Japan, 710-8602
        • Local Institution
      • Okayama-Shi, Okayama, Japan, 700-0082
        • Local Institution
      • Okayama-Shi, Okayama, Japan, 700-8505
        • Local Institution
      • Okayama-Shi, Okayama, Japan, 700-8511
        • Local Institution
      • Tsuyama-Shi, Okayama, Japan, 708-0841
        • Local Institution
    • Osaka
      • Kawachinagano-Shi, Osaka, Japan, 86-0008
        • Local Institution
      • Osaka-Shi, Osaka, Japan, 553-0003
        • Local Institution
      • Sakai-Shi, Osaka, Japan, 591-8025
        • Local Institution
      • Suita-Shi, Osaka, Japan
        • Local Institution
    • Saitama
      • Iruma-Gun, Saitama, Japan, 350-0495
        • Local Institution
    • Tokyo
      • Minato-Ku, Tokyo, Japan, 105-0001
        • Local Institution
      • Musashino-Shi, Tokyo, Japan, 180-0023
        • Local Institution
      • Shinjuku-Ku, Tokyo, Japan, 160-8582
        • Local Institution
      • Shinjuku-Ku, Tokyo, Japan, 162-8666
        • Local Institution
      • Shinjuku-Ku, Tokyo, Japan, 162-8655
        • Local Institution
    • Yamaguchi
      • Ube-Shi, Yamaguchi, Japan, 755-0067
        • Local Institution
    • Yamanashi
      • Nakakoma-Gun, Yamanashi, Japan, 409-3821
        • Local Institution

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

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Subjects who completed a previous entecavir Phase II studies (AI463047, 052 or 053);
  • ALT ≤ 10 x upper limit of normal;

  • Subjects must have well-compensated liver disease according to ALL of the following criteria;

    1. Prothrombin time ≤ 3 seconds prolonged compared to control value or INR ≤ 1.5
    2. Serum albumin ≥ 3 g/dL (≥ 30 g/L)
    3. Serum bilirubin ≤ 2.5 mg/dL (≤ 42.75 μmol/L)

Exclusion Criteria:

  • Sex and Reproductive Status Exceptions
  • Target Disease Exceptions
  • Medical History and Concurrent Diseases

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
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Entecavir
Medicin: Entecavir
Tablet, P.O. 0.5, 1 mg, once daily
Andre navne:
  • Baraclude
  • BMS-200475

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
To provide open-label entecavir to subjects who have completed previous blinded entecavir trials in Japan and are assessed by the investigator as likely to benefit from additional anti-hepatitis B therapy
Tidsramme: 24 weeks
24 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Incidence of clinical adverse events and discontinuations due to adverse events of entecavir for each cohort
Tidsramme: Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 post dosing
Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 post dosing
Incidence of laboratory abnormalities of of entecavir for each cohort
Tidsramme: Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 post dosing
Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 post dosing
Proportion of subjects HBeAg-positive at baseline who have loss of HBeAg from serum
Tidsramme: Day 1, Week 12, Week 24 and every subsequent 24 week during dosing
Day 1, Week 12, Week 24 and every subsequent 24 week during dosing
Proportion of subjects HBeAg-positive at baseline who achieve seroconversion (loss of HBeAg and appearance of HBeAb)
Tidsramme: Day 1, Week 12, Week 24 and every subsequent 24 week during dosing
Day 1, Week 12, Week 24 and every subsequent 24 week during dosing
Proportion of subjects with abnormal ALT at baseline who achieve normalization of serum ALT at Week 48
Tidsramme: Day 1, Week 48
Day 1, Week 48
Proportion of subjects who achieve HBV DNA levels by PCR assay less than the limit of quantification (LOQ)
Tidsramme: Day 1, Week 12, 24, and subsequent 24 week during dosing
Day 1, Week 12, 24, and subsequent 24 week during dosing
Proportion of subjects positive for HBeAg at baseline who achieve HBV DNA levels by PCR assay less than LOQ, normal serum ALT, and seroconversion
Tidsramme: Week 8, 16, 24 post dosing
Week 8, 16, 24 post dosing
Proportion of subjects negative for HBeAg at baseline who achieve HBV DNA levels by PCR assay less than LOQ and normal ALT and remain negative for HBeAg
Tidsramme: Day 1, Week 12, Week 24 and every subsequent 24 weeks during dosing
Day 1, Week 12, Week 24 and every subsequent 24 weeks during dosing
Proportion of subjects who achieved Complete Response during therapy, who have sustained Complete Response for 24 weeks after stopping drug
Tidsramme: 24 Week post dosing
24 Week post dosing
Proportion of subjects with histological improvement in the liver at Wks 48 & 96 [improvement in necroinflammatory score and no worsening of fibrosis at Wks 48 & 96 liver biopsy compared to baseline & to baseline in previous study]
Tidsramme: Week 48, 96
Week 48, 96
NChanges in liver histology as assessed by the New Inuyama Classification for histological assessment of chronic hepatitis
Tidsramme: Week 48 & Week 96
Week 48 & Week 96
Incidence of genotypic changes in HBV DNA polymerase conferring resistance to entecavir in subjects with confirmed ≥1 log10 increase in HBV DNA from nadir on treatment
Tidsramme: Week 2, 4, ± days, Week 8 every 4 weeks ± 7 days
Week 2, 4, ± days, Week 8 every 4 weeks ± 7 days

Samarbejdspartnere og efterforskere

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

Sponsor

Bristol-Myers Squibb

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

1. december 2003

Primær færdiggørelse (Faktiske)

1. december 2006

Studieafslutning (Faktiske)

1. december 2006

Datoer for studieregistrering

Først indsendt

17. december 2009

Først indsendt, der opfyldte QC-kriterier

17. december 2009

Først opslået (Skøn)

21. december 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

31. januar 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. januar 2011

Sidst verificeret

1. december 2009

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AI463-060

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 Kronisk hepatitis B

Kliniske forsøg med Entecavir

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Italy

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner