Back to resultsSB-497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Refractory Immune Thrombocytopenic Purpura (ITP)
Primary Purpose
Purpura, Thrombocytopaenic, Idiopathic
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SB497115
Sponsored by
About this trial
This is an interventional treatment trial for Purpura, Thrombocytopaenic, Idiopathic focused on measuring thrombopoietin, immune thrombocytopenic purpura, platelets, chronic thrombocytopenia
Eligibility 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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00102739
Brief Title
SB-497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Refractory Immune Thrombocytopenic Purpura (ITP)
Official Title
See Detailed Description
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Purpura, Thrombocytopaenic, Idiopathic
Keywords
thrombopoietin, immune thrombocytopenic purpura, platelets, chronic thrombocytopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SB497115
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Safety, tolerability, PK, PD, symptoms associated with ITP, and QoL, odds of response vs placebo during weeks 2 to 6 of the study.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Bad Nauheim
State/Province
Hessen
ZIP/Postal Code
61231
Country
Germany
Facility Name
GSK Investigational Site
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
GSK Investigational Site
City
Athens
Country
Greece
Facility Name
GSK Investigational Site
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
GSK Investigational Site
City
Pokfulam
Country
Hong Kong
Facility Name
GSK Investigational Site
City
Shatin
Country
Hong Kong
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
140-743
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Auckland
ZIP/Postal Code
1701
Country
New Zealand
Facility Name
GSK Investigational Site
City
Lahore
ZIP/Postal Code
54600
Country
Pakistan
Facility Name
GSK Investigational Site
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
GSK Investigational Site
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
GSK Investigational Site
City
Bucharest
ZIP/Postal Code
050098
Country
Romania
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
105 229
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
GSK Investigational Site
City
Maribor
ZIP/Postal Code
2000
Country
Slovenia
Facility Name
GSK Investigational Site
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Facility Name
GSK Investigational Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
GSK Investigational Site
City
ChiangMai
ZIP/Postal Code
50000
Country
Thailand
Facility Name
GSK Investigational Site
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
GSK Investigational Site
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG1 7AN
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Taunton
State/Province
Somerset
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
WC1E 6HX
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
18046028
Citation
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.
Results Reference
background
PubMed Identifier
20663993
Citation
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.
Results Reference
background
PubMed Identifier
23492914
Citation
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.
Results Reference
derived
PubMed Identifier
19231632
Citation
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.
Results Reference
derived
Learn more about this trial
SB-497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Refractory Immune Thrombocytopenic Purpura (ITP)
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