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

6 novembre 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

122

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

16 anni e precedenti (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Arm A

Entecavir + Lamivudine placebo (0-96 weeks)

Entecavir (96-240 weeks)
Droga: Entecavir
Tablets, Oral, 0.5 mg, once daily (0-96 weeks) and (96-240 weeks)
Altri nomi:
  • Baraclude
  • BMS-200475
Droga: Lamivudine Placebo
Capsules, Oral, 0 mg, once daily (0-96 weeks)
Comparatore attivo: Arm B

Lamivudine + Entecavir placebo (0-96 weeks)

Lamivudine (96-240 weeks)
Droga: Lamivudine

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

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

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants Who Achieved a Virologic Response at Week 24
Lasso di tempo: At Week 24
Virologic response=Hepatitis B virus DNA <300 copies/mL by polymerase chain reaction assay.
At Week 24

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Bristol-Myers Squibb

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2007

Completamento primario (Effettivo)

1 gennaio 2009

Completamento dello studio (Effettivo)

1 settembre 2013

Date di iscrizione allo studio

Primo inviato

26 ottobre 2006

Primo inviato che soddisfa i criteri di controllo qualità

26 ottobre 2006

Primo Inserito (Stima)

27 ottobre 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

26 novembre 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 novembre 2014

Ultimo verificato

1 novembre 2014

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • AI463-105

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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