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

4. august 2011 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

232

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Australien
      • Heidelburg, Australien
  • Canada
      • Winnipeg, Canada
  • Den Russiske Føderation
      • Moscow, Den Russiske Føderation
        • Novartis
  • Det Forenede Kongerige
      • London, Det Forenede Kongerige
  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater
    • Colorado
      • Denver, Colorado, Forenede Stater
    • Indiana
      • Indianapolis, Indiana, Forenede Stater
    • Minnesota
      • Rochester, Minnesota, Forenede Stater
    • New York
      • New York, New York, Forenede Stater
    • Texas
      • Houston, Texas, Forenede Stater
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater
  • Frankrig
      • Villejuif Cedex, Frankrig
  • Indien
      • New Delhi, Indien
        • Novartis
  • Israel
      • Tel Aviv, Israel
  • Kalkun
      • Istanbul, Kalkun
        • Novartis
  • Kina
      • Hong Kong, Kina
  • Korea, Republikken
      • Seoul, Korea, Republikken
  • Letland
      • Riga, Letland
        • Novartis
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Novartis
  • New Zealand
      • Auckland, New Zealand
  • Polen
      • Krakow, Polen
        • Novartis
  • Singapore
      • Singapore, Singapore
  • Spanien
      • Barcelona, Spanien
  • Taiwan
      • Taipei, Taiwan
  • Thailand
      • Bangkok, Thailand
  • Tyskland
      • Hannover, Tyskland
  • Vietnam
      • Hanoi, Vietnam
        • Novartis

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 til 70 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Telbivudine
600mg/day oral tablet for 104 weeks
Andre navne:
  • LDT600
Medicin: 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.
Medicin: Placebo
Telbivudine matching placebo or lamivudine matching placebo tablet.
Medicin: Lamivudine
100mg/day oral tablet for 104 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Sponsor

Novartis Pharmaceuticals

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

  • 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

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 2009

Datoer for studieregistrering

Først indsendt

20. januar 2004

Først indsendt, der opfyldte QC-kriterier

21. januar 2004

Først opslået (Skøn)

22. januar 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. september 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. august 2011

Sidst verificeret

1. august 2011

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CLDT600A2301

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 Hepatitis

Kliniske forsøg med Telbivudine

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Sponsorer og samarbejdspartnere

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Narkotikainterventioner

CROs by country

CROs in Azerbaijan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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