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

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00102739

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
Immune Thrombocytopenic Purpura	Drug: SB497115	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	See Detailed Description

Resource links provided by NLM:

Genetics Home Reference related topics: hemophilia thrombotic thrombocytopenic purpura

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.

Estimated Enrollment:	99
Study Start Date:	February 2005

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 91 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Bussel JB, Provan D, Shamsi T, Cheng G, Psaila B, Kovaleva L, Salama A, Jenkins JM, Roychowdhury D, Mayer B, Stone N, Arning M. Effect of eltrombopag on platelet counts and bleeding during treatment of chronic idiopathic thrombocytopenic purpura: a randomised, double-blind, placebo-controlled trial. Lancet. 2009 Feb 21;373(9664):641-8.

Bussel JB, Cheng G, Saleh MN, Psaila B, Kovaleva L, Meddeb B, Kloczko J, Hassani H, Mayer B, Stone NL, Arning M, Provan D, Jenkins JM. Eltrombopag for the treatment of chronic idiopathic thrombocytopenic purpura. N Engl J Med. 2007 Nov 29;357(22):2237-47.

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	TRA100773
Study First Received:	February 1, 2005
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00102739 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

platelets
thrombopoietin
immune thrombocytopenic purpura
chronic thrombocytopenia

Additional relevant MeSH terms:

Purpura
Signs and Symptoms
Skin Manifestations
Autoimmune Diseases
Hemorrhagic Disorders
Thrombocytopenia

Immune System Diseases
Hematologic Diseases
Blood Platelet Disorders
Blood Coagulation Disorders
Purpura, Thrombocytopenic, Idiopathic
Purpura, Thrombocytopenic

ClinicalTrials.gov processed this record on February 08, 2010