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Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis

4. august 2011 oppdatert av: Novartis Pharmaceuticals

Randomized, Double-Blind Trial of Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis

This research study was conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) versus Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the treatment of Hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking lamivudine.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Multicenter, multinational, randomized, double-blind study designed to compare the safety and efficacy of telbivudine (600 mg/day) versus lamivudine (100 mg/day) for 104 weeks in adults with decompensated chronic hepatitis B and evidence of cirrhosis. Patients were pre-stratified by screening Child-Turcotte-Pugh score (CTP score < 9 or ≥ 9) and ALT level (within normal limits (WNL) or > 1.0 x ULN) to help assure similar degrees of hepatic insufficiency and liver inflammation on both treatment arms. After 104 weeks of treatment, participants were followed-up with for an additional 16 weeks.

Studietype

Intervensjonell

Registrering (Faktiske)

232

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Australia
      • Heidelburg, Australia
  • Canada
      • Winnipeg, Canada
  • Den russiske føderasjonen
      • Moscow, Den russiske føderasjonen
        • Novartis
  • Forente stater
    • Arizona
      • Phoenix, Arizona, Forente stater
    • California
      • Los Angeles, California, Forente stater
    • Colorado
      • Denver, Colorado, Forente stater
    • Indiana
      • Indianapolis, Indiana, Forente stater
    • Minnesota
      • Rochester, Minnesota, Forente stater
    • New York
      • New York, New York, Forente stater
    • Texas
      • Houston, Texas, Forente stater
    • Wisconsin
      • Madison, Wisconsin, Forente stater
  • Frankrike
      • Villejuif Cedex, Frankrike
  • India
      • New Delhi, India
        • Novartis
  • Israel
      • Tel Aviv, Israel
  • Kina
      • Hong Kong, Kina
  • Korea, Republikken
      • Seoul, Korea, Republikken
  • Latvia
      • Riga, Latvia
        • Novartis
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Novartis
  • New Zealand
      • Auckland, New Zealand
  • Polen
      • Krakow, Polen
        • Novartis
  • Singapore
      • Singapore, Singapore
  • Spania
      • Barcelona, Spania
  • Storbritannia
      • London, Storbritannia
  • Taiwan
      • Taipei, Taiwan
  • Thailand
      • Bangkok, Thailand
  • Tyrkia
      • Istanbul, Tyrkia
        • Novartis
  • Tyskland
      • Hannover, Tyskland
  • Vietnam
      • Hanoi, Vietnam
        • Novartis

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

16 år til 70 år (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Documented decompensated chronic hepatitis B defined by all of the following: 1. Clinical history compatible with decompensated chronic hepatitis B related cirrhosis; 2. Child-Turcotte-Pugh score > 7 points.
  • Evidence of hepatic cirrhosis or portal hypertension.

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Patient is pregnant or breastfeeding.
  • Patient is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV), or Human immunodeficiency virus (HIV).
  • Patient previously received lamivudine, adefovir, or an investigational anti-hepatitis B virus (HBV) nucleoside or nucleotide analog at any time
  • Patient has received interferon or other immunomodulatory treatment for HBV infection in the 12 months before Screening for this study.

Other protocol-defined exclusion criteria may apply.

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: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Telbivudine 600 mg
Participants received Telbivudine 600 mg and a matching lamivudine placebo orally once a day for up to 104 weeks. Participants were followed-up for 16 weeks post-treatment.
Legemiddel: Telbivudine
600mg/day oral tablet for 104 weeks
Andre navn:
  • LDT600
Legemiddel: Placebo
Telbivudine matching placebo or lamivudine matching placebo tablet.
Aktiv komparator: Lamivudine 100 mg
Lamivudine 100 mg and a Telbivudine matching placebo orally once a day for up to 104 weeks. Participants were followed-up for 16 weeks post-treatment.
Legemiddel: Placebo
Telbivudine matching placebo or lamivudine matching placebo tablet.
Legemiddel: Lamivudine
100mg/day oral tablet for 104 weeks

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Clinical Response
Tidsramme: From Baseline to Week 52
Clinical response defined as achieving all of the following 3 criteria on at least 2 consecutive visits or at the last on-treatment visit: Serum hepatitis B virus (HBV) DNA < 4 log10 copies/mL, normal Alanine transaminase (ALT) level (ALT ≤ Upper Limit of Normal (ULN)), and improvement (a 2- point or greater reduction in Child-Turcotte-Pugh (CTP) score) or stabilization (not more than a 1-point change in CTP score), compared to the baseline value. CTP scores range from 5-15, higher scores indicate more liver impairment. For Improvement/Stabilization, either of the individual criteria were met.
From Baseline to Week 52

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to Initial Clinical Response
Tidsramme: From Baseline to Week 104
Time to Clinical Response defined as the number of days elapsed from the baseline visit to achieving initial Clinical Response.
From Baseline to Week 104
Duration of Initial Clinical Response
Tidsramme: Baseline to Week 104
Kaplan-Meier method was used. The duration was calculated as: date of last visit before initial loss of clinical response - date of initial clinical response occurred+1. If a patient did not lose clinical response, it was then censored at the efficacy overall censoring date.
Baseline to Week 104
Number of Participants With Improvement, Stabilization, and Worsening in Child-Turcotte-Pugh (CTP) Score at Week 52 and Week 104
Tidsramme: From Baseline to weeks 52 and 104
Child-Turcotte-Pugh (CTP) uses 2 clinical variables, ascites and encephalopathy, and 3 laboratory parameters, serum bilirubin, albumin, and prothrombin time. Each variable is assigned a score from 1 to 3, with the combined score comprising the CTP score range of 5 to 15 points. Higher scores indicate more impaired liver function. "Worsening" of CTP score was defined as a 2-point or greater increase from baseline, "improvement" in CTP score was defined as a 2-point or greater reduction from baseline, and "stabilization" of CTP score was defined as a change of 1-point or less from baseline.
From Baseline to weeks 52 and 104
Number of Participants With Improvement, Stabilization, and Worsening in a Modified (3-component) CTP Score
Tidsramme: Baseline and Week 104
Modified CTP was calculated using the 3 biochemical-components (serum bilirubin, albumin, and prothrombin). Total scores range from 3-9; higher scores indicate more liver impairment. Improvement was defined as 2-point or greater reduction in score from baseline. Stabilization comprises a score change of 1-point or less from baseline. Worsening of CTP score was defined as a 2-point or greater increase from baseline. The rationale for assessing changes in this modified (3-component) CTP score is that this maneuver removed the two subjective components of CTP scoring (ascites and encephalopathy).
Baseline and Week 104

Samarbeidspartnere og etterforskere

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

Sponsor

Novartis Pharmaceuticals

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.

Generelle publikasjoner

  • E.J. Gane, H.L. Chan, G. Choudhuri, D.J. Suh4, A. Chutaputti, R. Safadi, T. Tanwandee, S. Thongsawat, N. Assy, S.K. Sarin, W. Bao, A. Trylesinski, C. Avila. TREATMENT OF DECOMPENSATED HBV-CIRRHOSIS: RESULTS FROM 2-YEARS RANDOMIZED TRIAL WITH TELBIVUDINE OR LAMIVUDINE. Journal of Hepatology 52, Supplement 1, Page S4. April 2010

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. desember 2003

Primær fullføring (Faktiske)

1. desember 2009

Datoer for studieregistrering

Først innsendt

20. januar 2004

Først innsendt som oppfylte QC-kriteriene

21. januar 2004

Først lagt ut (Anslag)

22. januar 2004

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

5. september 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. august 2011

Sist bekreftet

1. august 2011

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CLDT600A2301

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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