Immune thrombocytopenic purpura (ITP)
Conditions
Interventions
Product Code: SB497115
Pharmaceutical Form: Tablet
CAS Number: CASRN 496775
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
GlaxoSmithKline Research and Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Diagnosed with chronic ITP for at least 6 months prior to screening, and have a platelet count of 1 year), or of childbearing potential and use one of the following acceptable methods of contraception from two weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study: •Complete abstinence from intercourse; •Intrauterine device (IUD); •Two forms of barrier contraception (diaphragm plus spermicide, and for males condom plus spermicide); •Male partner is sterile prior to entry into the study and is the only partner of the female; •Systemic contraceptives (combined or progesterone only). 7.Subject is ? 18 years old. 8.Subject has signed and dated written informed consent. 9.Subject is able to understand and comply with protocol requirements and instructions and intends to complete the study as planned. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Any clinically relevant abnormality, other than ITP, identified on the screening examination or any other medical condition or circumstance, which in the opinion of the Investigator, makes the subject unsuitable for participation in the study. 2.History of thrombosis within the last year. 3.Female subjects who are nursing or pregnant (positive serum or urine ?-human chorionic gonadotrophin pregnancy test) at screening or pre-dose on Day 1. 4.History of alcohol/drug abuse or dependence within 12 months of the study. 5.Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication. 6.Subject has consumed aspirin, aspirin-containing compounds, salicylates, anti-coagulants, quinine or non-steroidal anti-inflammatories (NSAIDs) for > 3 consecutive days within 2 weeks of the study start and until the end of the study. 7.Subject has consumed liquid antacids (e.g. Maalox™, Mylanta™, Amphogel™, milk of magnesia) or chewable antacids (e.g. TUMS™) within 48 hours of the first dose of study medication, and/or will require these medications during the 6-week dosing period. 8.Consumption of any herbal or dietary supplements, excluding vitamin or mineral supplements, within 1 week of the study start. 9.A complete blood count (CBC) and/or reticulocyte count outside the reference range, with the following exceptions: •platelet count < 30,000/?L is required for inclusion, •Hemoglobin: males ? 12.5 g/dL; females ? 11.5 g/dL are eligible for inclusion, •ANC ? 1500/?L (1.5 x 109/L) is eligible for inclusion. 10.History of platelet aggregation that prevents reliable measurement of platelet counts. 11.Any laboratory or clinical evidence for HIV infection; any clinical history or laboratory evidence for hepatitis C infection; any clinical history or laboratory evidence for chronic hepatitis B infection; or any evidence for active hepatitis at the time of subject screening. If a potential subject has no clinical history that would support HIV infection or hepatitis infection, no further laboratory screening is necessary; however, standard medical practice would suggest further evaluation of patients who have risk factors for these infections.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of SB-497115-GR as a thrombopoietic agent, when administered once daily for 6 weeks to adult patients with refractory chronic ITP. ;Primary end point(s): - Proportion of subjects with a platelet count of > 50,000/uL after 42 days of dosing (compared to baseline count of < 30,000/uL). Patients who meet this criterion will be referred to as treatment responders.; Secondary Objective: - To assess the safety and tolerability of SB-497115-GR when administered once daily for 6 weeks to adult patients with refractory chronic ITP. - To characterize the population pharmacokinetic profile of oral SB-497115-GR using a combined sparse and serial pharmacokinetic sampling strategy when administered once daily for 6 weeks to adult patients with refractory chronic ITP. - To determine the pharmacodynamic effect of SB-497115-GR on markers of thrombopoiesis when administered once daily for 6 weeks to adult patients with refractory chronic ITP. - To assess the impact of SB-497115-GR on the incidence and severity of symptoms of thrombocytopenia when administered once daily for 6 weeks to adult patients with refractory chronic ITP. - To assess the impact of SB-497115-GR on the quality of life when administered once daily for 6 weeks to adult patients with refractory chronic ITP. | — |
Countries
Denmark, Estonia, Germany, Ireland, Latvia, Spain, Sweden, United Kingdom
Outcome results
None listed