Last updated: 11/04/2018 12:54:52
SB-497115 (oral thrombopoietin receptor agonist) Versus Placebo In Adults With Refractory Immune Thrombocytopenic Purpura (ITP)
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: See Detailed Description
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: SB497115
Enrollment:
99
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
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;357(22):2237-47.
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]. 2010;
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;357(22):2237-2247.
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;373(9664):641-648.
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. 2010;
Siobhan Hayes, Daniele Ouellet, Jianping Zhang, Mary Wire, Ekaterina Gibiansky . Population PK/PD Modeling of Eltrombopag in Healthy Volunteers and Patients with Immune Thrombocytopenic Purpura and Optimization of Response-Guided Dosing. J Clin Pharmacol. 2010;
Tarantino M, 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;24(3):284-296.
Medical condition
Purpura, Thrombocytopaenic, Idiopathic
Product
eltrombopag
Collaborators
Not applicable
Study date(s)
February 2005 to January 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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.
- History of clotting disorder.
- Females who are pregnant or are receiving hormone replacement therapy or systemic contraceptives.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Reading, Berkshire, United Kingdom, RG1 7AN
Status
Study Complete
Location
GSK Investigational Site
Taunton, Somerset, United Kingdom, TA1 5DA
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-31-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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