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Status:

COMPLETED

SB-497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Refractory Immune Thrombocytopenic Purpura (ITP)

Lead Sponsor:

GlaxoSmithKline

Conditions:

Purpura, Thrombocytopaenic, Idiopathic

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

This study is a double-blind, randomized, placebo-controlled, parallel group, repeat-dose, study conducted in two parts (Part A and Part B) examining 30, 50, and 75 mg doses of SB-497115-GR as a treat...

Detailed Description

A double-blind, randomized, placebo-controlled, parallel group study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of SB-497119-GR, a thrombopoietin recepto...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Patients with chronic low platelet count (less than 30,000/µL) for 6 months who have failed at least one treatment for chronic low platelet count.
  • Patients receiving chronic maintenance steroid therapy must have received a stable dose for at least 1 month.
  • Normal PT and PTT.
  • Exclusion criteria:
  • History of clotting disorder.
  • Females who are pregnant or are receiving hormone replacement therapy or systemic contraceptives.
  • History of alcohol/drug abuse or dependence within 1 year.
  • Use of aspirin, aspirin-containing compounds, salicylates, antacids, rosuvastatin, pravastatin, non-steroidal anti-inflammatory drugs during the study and within 3 weeks prior to starting the study.
  • History of HIV infection or active infection with Hepatitis B or C.

Exclusion

    Key Trial Info

    Start Date :

    February 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2007

    Estimated Enrollment :

    99 Patients enrolled

    Trial Details

    Trial ID

    NCT00102739

    Start Date

    February 1 2005

    End Date

    January 1 2007

    Last Update

    April 15 2013

    Active Locations (30)

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    Page 1 of 8 (30 locations)

    1

    GSK Investigational Site

    Bad Nauheim, Hesse, Germany, 61231

    2

    GSK Investigational Site

    Athens, Greece, 10676

    3

    GSK Investigational Site

    Athens, Greece

    4

    GSK Investigational Site

    Thessaloniki, Greece, 57010