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A Study in Korea of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection

6. november 2014 opdateret af: Bristol-Myers Squibb

A Phase IV Study of the Antiviral Activity and Safety of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection Who Are Negative for Hepatitis B e Antigen in Korea

Entecavir, 0.5 mg daily, will have clinical efficacy (assessed as an undetectable hepatitis B DNA, <300 copies/mL, by Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction assay) that is comparable (noninferior) and potentially superior to lamivudine, 100 mg once daily, in adults with hepatitis B e antigen-negative chronic hepatitis B virus infection.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

122

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Korea, Republikken
      • Bucheon, Korea, Republikken, 420-717
        • Local Institution
      • Busan, Korea, Republikken, 602-739
        • Local Institution
      • Chuncheon, Korea, Republikken, 200-704
        • Local Institution
      • Daegu, Korea, Republikken, 700-721
        • Local Institution
      • Daegu, Korea, Republikken, 705-030
        • Local Institution
      • Daejeon, Korea, Republikken, 301-721
        • Local Institution
      • Guri, Korea, Republikken, 471-020
        • Local Institution
      • Jeonju, Korea, Republikken, 561-180
        • Local Institution
      • Seoul, Korea, Republikken, 135-710
        • Local Institution
      • Seoul, Korea, Republikken, 136-705
        • Local Institution
      • Seoul, Korea, Republikken, 130-702
        • Local Institution
      • Seoul, Korea, Republikken, 135-270
        • Local Institution
      • Seoul, Korea, Republikken, 138-040
        • Local Institution
      • Seoul, Korea, Republikken, 150-950
        • Local Institution
      • Seoul, Korea, Republikken, 152-050
        • 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

16 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Nucleoside and nucleotide-naive subjects with chronic HBV infection
  • Hepatitis B Surface antigen(HBsAg)-positive ≥6 months
  • Detectable HBsAg
  • HBV DNA ≥ 105 copies/mL by PCR
  • ALT 1.3 to 10 x the ULN
  • HBeAg negative, anti-hepatitis B Virus E antigen antibody (anti-HBeAb) positive status

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
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm A

Entecavir + Lamivudine placebo (0-96 weeks)

Entecavir (96-240 weeks)
Medicin: Entecavir
Tablets, Oral, 0.5 mg, once daily (0-96 weeks) and (96-240 weeks)
Andre navne:
  • Baraclude
  • BMS-200475
Medicin: Lamivudine Placebo
Capsules, Oral, 0 mg, once daily (0-96 weeks)
Aktiv komparator: Arm B

Lamivudine + Entecavir placebo (0-96 weeks)

Lamivudine (96-240 weeks)
Medicin: Lamivudine

Capsules, Oral, 100 mg, once daily (0-96 weeks)

Tablets, Oral, 100 mg, once daily (96-240 weeks)

Medicin: Entecavir Placebo
Tablets, Oral, 0 mg, once daily (0-96 weeks)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Who Achieved a Virologic Response at Week 24
Tidsramme: At Week 24
Virologic response=Hepatitis B virus DNA <300 copies/mL by polymerase chain reaction assay.
At Week 24

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Hepatitis B Virus (HBV) DNA <10^3, <10^4, or < 10^5 Copies/mL by Polymerase Chain Reaction (PCR) Assy at Weeks 24, 48, and 96
Tidsramme: At Weeks 24, 48, and 96
The number and percentage of participants achieving the following endpoints will be tabulated at each visit through Week 240 by treatment group: HBV DNA <300 copies/mL by PCR assay; HBV DNA <10^3, <10^4, or < 10^5 copies/mL by PCR assay. Treatment comparisons will be assessed using the same method as the primary endpoint.
At Weeks 24, 48, and 96
Mean Log10 Reduction From Baseline in Hepatitis B Virus (HBV) DNA at Weeks 24, 48, 96, 144, 192, and 240
Tidsramme: At Weeks 24, 48, 96, 144, 192, and 240
Mean log10 reduction from Baseline in HBV DNA virus by the Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction (PCR) assay at Week 24. The extent of the decrease was estimated by comparing HBV DNA levels of all participants in each group with a linear regression model with covariates of treatment and baseline HBV DNA by PCR assay.
At Weeks 24, 48, 96, 144, 192, and 240
Mean Laboratory Test Values for Alanine Aminotransferase (ALT) at Week 24
Tidsramme: At Week 24
Mean ALT values from baseline by laboratory test. .
At Week 24
Number of Participants With Normalization of Serum Alanine Aminotransferase (ALT) Levels at Weeks 24, 48, and 96
Tidsramme: At Weeks 24, 48, and 96
Normalization of serum ALT= ≤*institutional upper limit of normal.
At Weeks 24, 48, and 96
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Most Common AEs, and Grade 3/4 AEs at Week 24
Tidsramme: Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Most common AEs=AEs affecting ≥3 participants. Grade 3 (Severe)/Grade 4 (Very Severe)AEs per World Health Organization (WHO) criteria.Serious adverse events/deaths reported for enrolled patients regardless of treatment status.
Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period
Number of Participants With Elevations in Alanine Transaminase (ALT) and Aspartate Aminoaminase (AST) Levels, Elevations in ALT and AST Levels,Simultaneous Elevations in ALT and Total Bilirubin Levels, and ALT Flares at Week 24
Tidsramme: Start of dosing (Day 1) until end of treatment (24 weeks) + 5 days and to end of 24-week follow-up period
ALT flares=ALT>2*Baseline and 10*upper limit of normal. Serious adverse events/deaths reported for enrolled patients regardless of treatment status.
Start of dosing (Day 1) until end of treatment (24 weeks) + 5 days and to end of 24-week follow-up period
Number of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results by World Health Organization (WHO) Criteria at Week 24
Tidsramme: Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to the end of the 24-week follow-up period
ULN=upper limit of normal; ALT=alanine transaminase. WHO criteria: Grade 3=Severe (inability to carry out usual activity); Grade 4=Very severe (debilitating or significantly incapacitating patient despite symptomatic treatment).
Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to the end of the 24-week follow-up period
Number of Participants With Clinically or Statistically Significant Changes in Vital Sign Measurements at Week 24
Tidsramme: Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period
Vital signs assessed included blood pressure, heart rate, body temperature, and respiration rate.
Start of dosing (Day 1) until end of treatment (Week 24) + 5 days and to end of 24-week follow-up period
Number of Participants With Virologic Rebound at Week 24
Tidsramme: At Week 24
Virologic rebound was defined as a confirmed ≥1 log10 increase in hepatitis B virus (HBV) DNA from nadir on blinded treatment (as determined by 2 sequential HBV DNA measurements or last on-treatment measurement).
At Week 24
Percentage of Participants With a Virologic Response as Defined by Undetectable Hepatitis B Virus DNA at Weeks 48, 96, 144, 192, and 240
Tidsramme: At Weeks 48, 96, 144, 192, and 240
Undetectable HBV DNA= <300 copies/mL by polymerase chain reaction assay
At Weeks 48, 96, 144, 192, and 240
Number of Participants With Viral Rebound and Drug-resistant Hepatitis B Virus (HBV) DNA Mutations at Week 96
Tidsramme: At 96 weeks
Virologic rebound was defined as a confirmed ≥1 log10 increase in HBV DNA from nadir on blinded treatment (as determined by 2 sequential HBV DNA values or last on-treatment measurement).
At 96 weeks
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Most Common AEs, and Grade 3/4 AEs at Week 240
Tidsramme: Start of dosing (Day 1) until end of treatment (Week 240) + 5 days
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Start of dosing (Day 1) until end of treatment (Week 240) + 5 days
Number of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results by World Health Organization (WHO) Criteria at Week 96
Tidsramme: Start of dosing (Day 1) until Week 96
ULN=upper limit of normal; ALT=alanine transaminase. WHO criteria: Grade 3=Severe (inability to carry out usual activity); Grade 4=Very severe (debilitating or significantly incapacitating patient despite symptomatic treatment).
Start of dosing (Day 1) until Week 96

Samarbejdspartnere og efterforskere

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

Sponsor

Bristol-Myers Squibb

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. februar 2007

Primær færdiggørelse (Faktiske)

1. januar 2009

Studieafslutning (Faktiske)

1. september 2013

Datoer for studieregistrering

Først indsendt

26. oktober 2006

Først indsendt, der opfyldte QC-kriterier

26. oktober 2006

Først opslået (Skøn)

27. oktober 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. november 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. november 2014

Sidst verificeret

1. november 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AI463-105

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 Malta

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner