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

NCT ID: NCT00102739

Last Updated: 2013-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-01-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Purpura, Thrombocytopaenic, Idiopathic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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SB497115

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Bad Nauheim, Hesse, Germany

Site Status

GSK Investigational Site

Athens, , Greece

Site Status

GSK Investigational Site

Athens, , Greece

Site Status

GSK Investigational Site

Thessaloniki, , Greece

Site Status

GSK Investigational Site

Pokfulam, , Hong Kong

Site Status

GSK Investigational Site

Shatin, , Hong Kong

Site Status

GSK Investigational Site

Auckland, , New Zealand

Site Status

GSK Investigational Site

Lahore, , Pakistan

Site Status

GSK Investigational Site

Lodz, , Poland

Site Status

GSK Investigational Site

Bucharest, , Romania

Site Status

GSK Investigational Site

Bucharest, , Romania

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Moscow, , Russia

Site Status

GSK Investigational Site

Novosibirsk, , Russia

Site Status

GSK Investigational Site

Ljubljana, , Slovenia

Site Status

GSK Investigational Site

Maribor, , Slovenia

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Seoul, , South Korea

Site Status

GSK Investigational Site

Taipei, , Taiwan

Site Status

GSK Investigational Site

Bangkok, , Thailand

Site Status

GSK Investigational Site

Chiang Mai, , Thailand

Site Status

GSK Investigational Site

Khon Kaen, , Thailand

Site Status

GSK Investigational Site

Reading, Berkshire, United Kingdom

Site Status

GSK Investigational Site

Taunton, Somerset, United Kingdom

Site Status

GSK Investigational Site

Liverpool, , United Kingdom

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

GSK Investigational Site

Manchester, , United Kingdom

Site Status

GSK Investigational Site

Swansea, , United Kingdom

Site Status

Countries

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Germany Greece Hong Kong New Zealand Pakistan Poland Romania Russia Slovenia South Korea Taiwan Thailand United Kingdom

References

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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. doi: 10.1056/NEJMoa073275.

Reference Type BACKGROUND
PMID: 18046028 (View on PubMed)

Gibiansky E, Zhang J, Williams D, Wang Z, Ouellet D. Population pharmacokinetics of eltrombopag in healthy subjects and patients with chronic idiopathic thrombocytopenic purpura. J Clin Pharmacol. 2011 Jun;51(6):842-56. doi: 10.1177/0091270010375427. Epub 2010 Jul 27.

Reference Type BACKGROUND
PMID: 20663993 (View on PubMed)

Tarantino MD, Fogarty P, Mayer B, Vasey SY, Brainsky A. Efficacy of eltrombopag in management of bleeding symptoms associated with chronic immune thrombocytopenia. Blood Coagul Fibrinolysis. 2013 Apr;24(3):284-96. doi: 10.1097/MBC.0b013e32835fac99.

Reference Type DERIVED
PMID: 23492914 (View on PubMed)

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. doi: 10.1016/S0140-6736(09)60402-5.

Reference Type DERIVED
PMID: 19231632 (View on PubMed)

Other Identifiers

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TRA100773

Identifier Type: -

Identifier Source: org_study_id

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