NCT00102739

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 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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2005

Geographic Reach
13 countries

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2005

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

April 15, 2013

Status Verified

November 1, 2012

Enrollment Period

1.9 years

First QC Date

February 1, 2005

Last Update Submit

April 11, 2013

Conditions

Purpura, Thrombocytopaenic, Idiopathic

Keywords

thrombopoietinimmune thrombocytopenic purpuraplateletschronic thrombocytopenia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

Interventions

SB497115DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

GSK Investigational Site

Bad Nauheim, Hesse, 61231, Germany

Location

GSK Investigational Site

Athens, 10676, Greece

Location

GSK Investigational Site

Athens, Greece

Location

GSK Investigational Site

Thessaloniki, 57010, Greece

Location

GSK Investigational Site

Pokfulam, Hong Kong

Location

GSK Investigational Site

Shatin, Hong Kong

Location

GSK Investigational Site

Auckland, 1701, New Zealand

Location

GSK Investigational Site

Lahore, 54600, Pakistan

Location

GSK Investigational Site

Lodz, 93-510, Poland

Location

GSK Investigational Site

Bucharest, 022328, Romania

Location

GSK Investigational Site

Bucharest, 050098, Romania

Location

GSK Investigational Site

Moscow, 105 229, Russia

Location

GSK Investigational Site

Moscow, 125167, Russia

Location

GSK Investigational Site

Novosibirsk, 630087, Russia

Location

GSK Investigational Site

Ljubljana, 1000, Slovenia

Location

GSK Investigational Site

Maribor, 2000, Slovenia

Location

GSK Investigational Site

Seoul, 136-705, South Korea

Location

GSK Investigational Site

Seoul, 138-736, South Korea

Location

GSK Investigational Site

Seoul, 140-743, South Korea

Location

GSK Investigational Site

Taipei, 114, Taiwan

Location

GSK Investigational Site

Bangkok, 10330, Thailand

Location

GSK Investigational Site

Chiang Mai, 50000, Thailand

Location

GSK Investigational Site

Khon Kaen, 40002, Thailand

Location

GSK Investigational Site

Reading, Berkshire, RG1 7AN, United Kingdom

Location

GSK Investigational Site

Taunton, Somerset, TA1 5DA, United Kingdom

Location

GSK Investigational Site

Liverpool, L7 8XP, United Kingdom

Location

GSK Investigational Site

London, E1 1BB, United Kingdom

Location

GSK Investigational Site

London, WC1E 6HX, United Kingdom

Location

GSK Investigational Site

Manchester, M13 9WL, United Kingdom

Location

GSK Investigational Site

Swansea, SA6 6NL, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 18046028BACKGROUND

  • 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.

    PMID: 20663993BACKGROUND

  • 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.

    PMID: 23492914DERIVED

  • 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.

    PMID: 19231632DERIVED

MeSH Terms

Conditions

PurpuraJacobs syndromePurpura, Thrombocytopenic, Idiopathic

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Blood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and SymptomsPurpura, ThrombocytopenicThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2005

First Posted

February 2, 2005

Study Start

February 1, 2005

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

April 15, 2013

Record last verified: 2012-11

Locations

SL(2)PA(1)TW(1)DE(1)PL(1)RU(3)TH(3)NZ(1)GB(7)KR(3)HK(2)RO(2)GR(3)