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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00102739
First received: February 1, 2005
Last updated: April 11, 2013
Last verified: November 2012
History of Changes
  Purpose

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 treatment for patients with ITP who have failed prior therapy. The study is designed to determine the proportion of patients with a platelet count =50,000/µL after 42 days. In Part B, 99 newly-recruited subjects will be randomized to one of two dosing arms in a 2:1 ratio of active:placebo. During the 6 week study period, subjects will start on placebo or active drug (50 mg) and may have a dose increase to 75 mg based upon their platelet count at day 22.


Condition Intervention Phase
Purpura, Thrombocytopaenic, Idiopathic
 Drug: SB497115
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Treatment response, assessed by the proportion of patients with platelet counts of =50, 000/µL (compared with baseline count of <30, 000/µL) after 42 days of treatment.

Secondary Outcome Measures:
  • Safety, tolerability, PK, PD, symptoms associated with ITP, and QoL, odds of response vs placebo during weeks 2 to 6 of the study.

Enrollment: 99
Study Start Date: February 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: SB497115
    Other Name: SB497115
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 receptor agonist, administered at 30, 50, and 75 mg as oral tablets once-daily for 6 weeks to adult male and female subjects with refractory, chronic immune thrombocytopenia purpura

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00102739

  Show 30 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00102739     History of Changes
Other Study ID Numbers: TRA100773
Study First Received: February 1, 2005
Last Updated: April 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
thrombopoietin
immune thrombocytopenic purpura
platelets
chronic thrombocytopenia

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
 Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases

ClinicalTrials.gov processed this record on May 21, 2013