None listed
Conditions
Interventions
PART A GROUP 1 Type of group
30 mg of SB-497115-GR will be administered once a day for 6 weeks
Group name:PART B GROUP 2 Type of group
SB-497115-GR PLACEBO will be administered once a day for 6 weeks.
Sponsors
GLAXOSMITHKLINE PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of chronic ITP at least 6 months before the count with platelet count 18 years old. 8. The subject has signed and dated the written informed consent. 9. The subject is capable of understanding and adhering to the requirements and instructions of the protocol, and intends to complete the study as planned.
Exclusion criteria
Exclusion criteria: 1. Any relevant clinical abnormality, different from PTI. 2. History of thrombosis within the previous year. 3. Women who are breastfeeding or pregnant during the screening or before the dose on Day 1. 4. History of alcohol or drug abuse or dependence within 12 months prior to inclusion in the study. 5. Treatment with any investigational medication in the 30 days or 5 half-lives prior to the administration of the first dose of the study medication. 6. The subject has consumed aspirin, compounds containing aspirin, salicylates, anticoagulants, quinine or non-steroidal anti-inflammatory drugs (NSAIDs) for> 3 consecutive days in the 2 weeks prior to the start of the study. 7. The subject has consumed liquid antacids or chewable antacids within 48 hours prior to the first dose of the study medication or will require these medications during the 6-week dosing period. 8. Consumption of any food or herbal supplement, except vitamin or mineral supplements, within the week prior to the start of the study. 9. Complete cytology (HCC) or reticulocyte count outside of normal limits. 10. History of platelet aggregation that prevents the reliable measurement of the platelet count. 11. Any laboratory or clinical evidence of HIV infection, hepatitis C, hepatitis B or any evidence of active hepatitis at the time of subject scrutiny.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Complete blood cell count (includes platelet count) Measure:Efficacy of the treatment: Percentage of responding patients, those who in 42 days of treatment achieve a platelet count equal to or greater than 50,000 Timepoints:Basal, days 1, 8, 15, 22, 29, 36, 43. And during the follow-up: Days 57, 71, 85. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Physical exam. Evaluation of vital signs. 12-lead ECG. Splenic evaluation with ultrasonography. Lab tests. Aggregation and platelet activation. Notification of adverse effects. Measure: 37/5000 Safety and tolerance to treatment Timepoints: 387/5000 Physical exam. Evaluation of vital signs: Days 1, 8, 15, 22, 29, 36, 43, 57, 71 and 86. 12-lead ECG: Days 1, 22, 34, 71 Ultrasonography: Days 1, 22, 43 Tests of serum biochemistry, hemotological and urinalysis: Days 1, 8, 15, 22, 29, 36, 43, 57, 71 and 86. Aggregation and platelet activation: Days 1, 22, 43, 85 Notification of adverse events: At the time of presentation. ; Outcome name:Debug (CL / F) of SB-497115-GR. Abstraction speed constant (ka) of SB-497115-GR. Volume of distribution (V / F) of SB-497115-GR. Measure:Parameters of pharmacokinetics Timepoints:It can be taken on any day of the study, but is preferred as soon as possible. ; Outcome name:Questionnaire SF-36v2QOL Measure:Physical and mental state of the patient Timepoints:At the end of the treatment | — |
Countries
Australia, Brazil, Canada, China, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Korea South, Latovia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Romania, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kindgdom, United States
Outcome results
None listed