Purpura, Thrombocytopaenic, Idiopathic
Conditions
Keywords
thrombopoietin, immune thrombocytopenic purpura, platelets, chronic thrombocytopenia
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
Interventions
DRUGSB497115
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Safety, tolerability, PK, PD, symptoms associated with ITP, and QoL, odds of response vs placebo during weeks 2 to 6 of the study. | — |
Countries
Germany, Greece, Hong Kong, New Zealand, Pakistan, Poland, Romania, Russia, Slovenia, South Korea, Taiwan, Thailand, United Kingdom
Outcome results
None listed