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

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ClinicalTrials.gov Identifier: NCT00102739
Recruitment Status : Completed
First Posted : February 2, 2005
Last Update Posted : April 15, 2013
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Purpura, Thrombocytopaenic, Idiopathic Drug: SB497115 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: See Detailed Description
Study Start Date : February 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007





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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102739


Locations
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Germany
GSK Investigational Site
Bad Nauheim, Hessen, Germany, 61231
Greece
GSK Investigational Site
Athens, Greece, 10676
GSK Investigational Site
Athens, Greece
GSK Investigational Site
Thessaloniki, Greece, 57010
Hong Kong
GSK Investigational Site
Pokfulam, Hong Kong
GSK Investigational Site
Shatin, Hong Kong
Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 136-705
GSK Investigational Site
Seoul, Korea, Republic of, 138-736
GSK Investigational Site
Seoul, Korea, Republic of, 140-743
New Zealand
GSK Investigational Site
Auckland, New Zealand, 1701
Pakistan
GSK Investigational Site
Lahore, Pakistan, 54600
Poland
GSK Investigational Site
Lodz, Poland, 93-510
Romania
GSK Investigational Site
Bucharest, Romania, 022328
GSK Investigational Site
Bucharest, Romania, 050098
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 105 229
GSK Investigational Site
Moscow, Russian Federation, 125167
GSK Investigational Site
Novosibirsk, Russian Federation, 630087
Slovenia
GSK Investigational Site
Ljubljana, Slovenia, 1000
GSK Investigational Site
Maribor, Slovenia, 2000
Taiwan
GSK Investigational Site
Taipei, Taiwan, 114
Thailand
GSK Investigational Site
Bangkok, Thailand, 10330
GSK Investigational Site
ChiangMai, Thailand, 50000
GSK Investigational Site
Khon Kaen, Thailand, 40002
United Kingdom
GSK Investigational Site
Reading, Berkshire, United Kingdom, RG1 7AN
GSK Investigational Site
Taunton, Somerset, United Kingdom, TA1 5DA
GSK Investigational Site
Liverpool, United Kingdom, L7 8XP
GSK Investigational Site
London, United Kingdom, E1 1BB
GSK Investigational Site
London, United Kingdom, WC1E 6HX
GSK Investigational Site
Manchester, United Kingdom, M13 9WL
GSK Investigational Site
Swansea, United Kingdom, SA6 6NL
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00102739    
Other Study ID Numbers: TRA100773
First Posted: February 2, 2005    Key Record Dates
Last Update Posted: April 15, 2013
Last Verified: November 2012
Keywords provided by GlaxoSmithKline:
thrombopoietin
immune thrombocytopenic purpura
platelets
chronic thrombocytopenia
Additional relevant MeSH terms:
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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