Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

SB497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Thrombocytopenia Due To Hepatitis C

31. maj 2012 opdateret af: GlaxoSmithKline

A Double-Blind, Randomized, Placebo-Controlled, Multi-Centre, Dose-Ranging, Parallel Group, Phase II Study to Assess Efficacy, Safety/Tolerability, and Pharmacokinetics of a Thrombopoietin Receptor Agonist, SB-497115-GR, When Administered as 30, 50, and 75 mg Once Daily for 12 Weeks in Subjects With

SB497115 is an oral agent which activates the thrombopoietin receptor and increases platelet counts in healthy volunteers. This study is examining several different doses of SB497115 as a treatment for patients with chronic hepatitis C-related thrombocytopenia who are potential candidates for antiviral treatment with pegylated interferon and ribavirin. The study will be conducted in two phases, Parts 1 and 2. In Part 1, study subjects will be randomized to 4 weeks of SB-497115-GR or placebo administered daily without antiviral therapy. Subjects who successfully complete Part 1 (platelet count 70,000/µL for Pegasys and platelet count 100,000/µL for PEG-Intron) will then proceed to Part 2. In Part 2, subjects will receive an additional 8 weeks of SB-497115-GR or placebo administered daily with antiviral therapy.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A Double-Blind, Randomized, Placebo-Controlled, Multi-Centre, Dose-Ranging, Parallel Group, Phase II Study to Assess Efficacy, Safety/Tolerability, and Pharmacokinetics of a Thrombopoietin Receptor Agonist, SB-497115-GR, when Administered as 30, 50, and 75 mg Once Daily for 12 weeks in Subjects with Chronic Hepatitis C-Related Thrombocytopenia who are Potential Candidates for Antiviral Treatment with Pegylated Interferon and Ribavirin.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

75

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Det Forenede Kongerige
      • London, Det Forenede Kongerige, NW3 2QG
        • GSK Investigational Site
      • London, Det Forenede Kongerige, W2 1NY
        • GSK Investigational Site
    • Gloucestershire
      • Bristol, Gloucestershire, Det Forenede Kongerige, BS2 8HW
        • GSK Investigational Site
    • Lanarkshire
      • Glasgow, Lanarkshire, Det Forenede Kongerige, G12 0YN
        • GSK Investigational Site
    • Nottinghamshire
      • Nottingham, Nottinghamshire, Det Forenede Kongerige, NG7 2UH
        • GSK Investigational Site
  • Forenede Stater
    • Colorado
      • Denver, Colorado, Forenede Stater, 80262
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • GSK Investigational Site
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202
        • GSK Investigational Site
    • Missouri
      • St. Louis, Missouri, Forenede Stater, 63104
        • GSK Investigational Site
    • New York
      • New York, New York, Forenede Stater, 10021
        • GSK Investigational Site
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • GSK Investigational Site
    • Texas
      • San Antonio, Texas, Forenede Stater, 78215
        • GSK Investigational Site
    • Virginia
      • Fairfax, Virginia, Forenede Stater, 22031
        • GSK Investigational Site
      • Richmond, Virginia, Forenede Stater, 23249
        • GSK Investigational Site
  • Frankrig
      • Clermont Ferrand Cédex 1, Frankrig, 63058
        • GSK Investigational Site
      • Clichy Cedex, Frankrig, 92118
        • GSK Investigational Site
      • Lyon, Frankrig, 69437
        • GSK Investigational Site
      • Lyon Cedex 02, Frankrig, 69288
        • GSK Investigational Site
      • Marseille Cedex 08, Frankrig, 13285
        • GSK Investigational Site
      • Nice Cedex 03, Frankrig, 06202
        • GSK Investigational Site
      • Paris Cedex 12, Frankrig, 75571
        • GSK Investigational Site
      • Pessac Cedex, Frankrig, 33604
        • GSK Investigational Site
      • Vandoeuvre Les Nancy, Frankrig, 54511
        • GSK Investigational Site
  • Puerto Rico
      • San Juan, Puerto Rico, 00909-1711
        • GSK Investigational Site
  • Tyskland
      • Berlin, Tyskland, 13353
        • GSK Investigational Site
      • Hamburg, Tyskland, 20246
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Heidelberg, Baden-Wuerttemberg, Tyskland, 69120
        • GSK Investigational Site
    • Hessen
      • Frankfurt, Hessen, Tyskland, 60590
        • GSK Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Tyskland, 30625
        • GSK Investigational Site
    • Saarland
      • Homburg, Saarland, Tyskland, 66421
        • GSK Investigational Site

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

  • Chronic low platelet count between 20,000 and <70,000/µL.
  • Prior liver biopsy indicating chronic hepatitis within the previous 5 years or radiographic evidence of cirrhosis and / or endoscopic evidence of non-bleeding esophageal or gastric varices.

Exclusion criteria:

  • History of heart attack or abnormal heart function.
  • History of thrombosis within 1 year.
  • History of alcohol or drug abuse or dependence within 1 year.
  • Use of aspirin, aspirin-containing compounds, salicylates, antacids.
  • History of HIV infection or active infection with Hepatitis B or C.
  • Females who are pregnant.
  • Patients using non-steroidal anti-inflammatory drugs during the study and within 3 weeks prior to starting the study.

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
Aktiv komparator: Arm B
SB-497115-GR 30mg administered orally daily for 12 weeks beginning 4 weeks prior to initiating 8 weeks of antiviral therapy and for 8 weeks during weekly antiviral therapy.
Medicin: SB497115
Approximately 160 subjects will be randomized equally to one of four treatment groups of approximately 40 subjects (A-D). Subjects will receive oral tablets of SB-497115-GR at 30mg, 50 mg, 75 mg or placebo administered once daily for a total of 12 weeks beginning 4 weeks prior to initiating 8 weeks of antiviral therapy and for 8 weeks during weekly antiviral therapy.
Aktiv komparator: Arm C
SB-497115-GR 50mg administered orally daily for 12 weeks beginning 4 weeks prior to initiating 8 weeks of antiviral therapy and for 8 weeks during weekly antiviral therapy.
Medicin: SB497115
Approximately 160 subjects will be randomized equally to one of four treatment groups of approximately 40 subjects (A-D). Subjects will receive oral tablets of SB-497115-GR at 30mg, 50 mg, 75 mg or placebo administered once daily for a total of 12 weeks beginning 4 weeks prior to initiating 8 weeks of antiviral therapy and for 8 weeks during weekly antiviral therapy.
Aktiv komparator: Arm D
SB-497115-GR 75mg administered orally daily for 12 weeks beginning 4 weeks prior to initiating 8 weeks of antiviral therapy and for 8 weeks during weekly antiviral therapy.
Medicin: SB497115
Approximately 160 subjects will be randomized equally to one of four treatment groups of approximately 40 subjects (A-D). Subjects will receive oral tablets of SB-497115-GR at 30mg, 50 mg, 75 mg or placebo administered once daily for a total of 12 weeks beginning 4 weeks prior to initiating 8 weeks of antiviral therapy and for 8 weeks during weekly antiviral therapy.
Placebo komparator: Arm A
Placebo administered orally daily for 12 weeks beginning 4 weeks prior to initiating 8 weeks of antiviral therapy and for 8 weeks during weekly antiviral therapy.
Andet: Placebo
Placebo administered orally daily for 12 weeks beginning 4 weeks prior to initiating 8 weeks of antiviral therapy and for 8 weeks during weekly antiviral therapy.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Treatment response, assessed by the proportion of subjects with a shift from baseline platelet count (20, 000 to <70,000µL) to =100,000/µL after 4 weeks of study treatment.
Tidsramme: 4 weeks
4 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Mean increase in platelet counts and markers of thrombopoiesis. Safety and tolerability, population PK, pharmacodynamics. Effect of antiviral outcome measures during and after therapy.
Tidsramme: 4 weeks
4 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

GlaxoSmithKline

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. april 2005

Primær færdiggørelse (Faktiske)

1. oktober 2006

Studieafslutning (Faktiske)

1. november 2006

Datoer for studieregistrering

Først indsendt

13. maj 2005

Først indsendt, der opfyldte QC-kriterier

13. maj 2005

Først opslået (Skøn)

16. maj 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. juni 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. maj 2012

Sidst verificeret

1. marts 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TPL102357

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 .

Abonner