SB-497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Refractory Immune Thrombocytopenic Purpura (ITP)
- Conditions
- -D693 Idiopathic thrombocytopenic purpuraD693Idiopathic thrombocytopenic purpura
- Registration Number
- PER-041-05
- Lead Sponsor
- GLAXOSMITHKLINE PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
1. Diagnosis of chronic ITP at least 6 months before the count with platelet count <30,000 / p.L.
2. Refractory patients who have not responded to one or more previous treatments or who have relapsed during the 3 months of previous treatment.
3. Subjects on maintenance immunosuppressive therapy should be receiving a dose that has been stable for at least 1 month.
4. No pre-existing heart disease.
5. Normal prothrombin time (TP / INR) and activated partial thromboplastin time (aPTT), with no history of coagulation alterations other than ITP.
6. The subject practices an acceptable method of contraception. Women (or female partners of male subjects) should not be of reproductive age, or be of reproductive age and use any of the acceptable contraceptive methods.
7. The subject must be> 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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Complete blood cell count (includes platelet count)<br>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<br>Timepoints:Basal, days 1, 8, 15, 22, 29, 36, 43. And during the follow-up: Days 57, 71, 85.<br>
- Secondary Outcome Measures
Name Time Method