None listed
Conditions
Interventions
This group will be treated with Eltrombopag with an individualized dose, which will start with 50 mg daily but may increase up to 75 mg or decrease up to 25 mg. The dose that will be maintained will be the one that allows to maintain the number of platelets in 50 000 to more in the long term. The administration will be PO, QD, in tablets, until the approval of eltrombopag for long-term use in subjects with ITP by the regulatory authorities in most of the participating countries.
Sponsors
GLAXOSMITHKLINE PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • 1. The subject has signed the written informed consent form. 2. Adults (≥18 years) with a diagnosis of ITP. 3. Randomization and previous termination of treatment and follow-up periods in any of the studies of eltrombopag for ITP. 4. The subjects previously recruited in the TRA 100773 study must have completed the prescribed ophthalmic evaluation at 6-month follow-up without having found any ocular event of clinical concern. 5. Subjects previously recruited in the TRA 102537 RAISE Study must have completed the treatment and follow-up periods defined in that protocol. 6. Subjects who have not experienced any EAS related to eltrombopag or any intolerance to any other medication in previous studies of eltrombopag. 7. Subjects who do not have any intercurrent medical event. 8. Ophthalmological examinations performed in previous studies that have not identified ocular events of clinical concern. 9. Subjects must have had an initial response to a previous treatment for ITP or have had a bone marrow biopsy compatible with ITP in the previous 3 years to rule out myelodysplasia or some other cause of thrombocytopenia. 10. Previous treatments for PTI with immunoglobulins and cyclophosphamide that have been completed at least 4 weeks before Day 1. 11. Subjects treated with corticosteroids should be receiving a dose that has been stable at least 1 month before Day 1 of the study. 12. Normal prothrombin time (TP and INR) and activated partial thromboplastin time (aPTT) also normal, with no history of any hypercoagulable state. 13. Complete blood count (CBC), within the reference intervals. 14. The following blood chemistry values ​​should be within the normal reference values: creatinine, ALT, AST, total bilirubin, total albumin and alkaline phosphatase. 15. The subject practices some acceptable contraceptive method. Women (or female partners of male subjects) must not be of childbearing age, or be of childbearing age and use some acceptable contraceptive method from two weeks before the study drug administration, throughout the study and up to 28 days after completing the study or having been withdrawn prematurely. 16. The subject has the ability to understand and adhere to the requirements and instructions of the protocol.
Exclusion criteria
Exclusion criteria: 1. Any abnormality of clinical relevance, different from the PTI or any other problem or medical circumstance that makes the subject not suitable to participate in the study or indicate another diagnosis. 2. History of malignancy. 3. History of arterial or venous thrombosis. 4. History of arterial or venous thrombosis AND ≥ 2 of the following risk factors: Leiden Factor V, hormone replacement therapy, systemic contraceptives, smoking, diabetes, hypercholesterolemia, antihypertensive medications or cancer. 5. Pre-existing heart disease or clinically important findings on the resting ECG of 12 leads. 6. Lactating or pregnant women. 7. History of alcohol or drug abuse. 8. Treatment with a product under investigation in the previous 30 days or five half-lives (whichever is longer) before the first dose of study medication. 9. Subjects treated with aspirin, compounds containing aspirin, salicylates, anticoagulants, quinine or nonsteroidal anti-inflammatory drugs (NSAIDs) for> 3 consecutive days in the 2 weeks prior to the start of the study and until the end of it. 10. Consumption of any herbal or dietary supplement. 11. History of alterations in platelet aggregation. 12. All subjects with secondary immune thrombocytopenia. 13. Subject who is planning to undergo cataract surgery. 14. In France, a person who is not affiliated with or is a beneficiary of any category of social insurance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:1) Laboratory tests: Panels of hematology, coagulation and serum chemistry, urinalysis. 2) Eye exams: Visual acuity will be evaluated with manual or automated refraction, the ocular anatomy of the anterior structures with slit lamp, using the protocol for graduation of the lens opacity of the Age-Related Eye Disease Study (EEORE) . An indirect biomicroscopy of the characteristics of the posterior and peripheral retina will also be performed. 3) Adverse events: Clinical evaluation to determine any undesirable medical occurrence in a patient that is considered related, or not, related to the research product. Measure:Safety and tolerance: 1) Laboratory tests. 2) Eye exams. 3) Frequency of all adverse events. Timepoints:1) Panels of hematology and serum chemistry, adverse events: Day 1 and weeks 1, 2 3 and 4 of each stage. 2) Urine analysis and coagulation panel: Before starting the treatment. 3) Eye exams: Before starting treatment and every 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:1) Platelet count in peripheral blood, to identify subjects who reached values ​​of 30.00 and 50,000 platelets per microliter and the amount of time they could maintain these figures. 2) Clinical evaluation to identify the number of patients that require or not, the use of concomitant medications to maintain platelet levels ≥ 50,000. Patients who require rescue medication (new medication, increased dose of concomitant medication, platelet transfusion or splenectomy) will also be identified. 3) Application of the WHO Bleeding Scale and the PTI Hemorrhage Scale: To identify the incidence and severity of the signs and symptoms of ITP. 4) Brief Form of Confidence in Medical Outcomes 36 (SF-36v2), the brief Form of the Motivation and Energy Scale (MEI-SF), the FACIT-Fatigue Subscale of the symptoms alone, and relevant questions on hemorrhage and bruising from the FACT-Thrombocytopenia subscale: To assess the quality of life, severity of fatigue, motivation, energy, haemorrhage and bruising, and physical and mental health status. Measure:1) Proportion of subjects with a platelet count ≥ 50,000 / uL during treatment. 2) Proportion of subjects with a platelet count ≥ 30,000 / uL during treatment. 3) Maximum duration of the elevation of the platelet count ≥ 50,000 / uL. 4) Maximum duration of the elevation of the platelet count ≥ 30,000 / uL. 5) Effect of eltrombopag on the reduction of concomitant treatments. 6) Proportion of subjects who achieve stable platelet counts ≥ 50,000 / uL without concomitant medications. 7) Proportion of subjects requiring rescue treatment. 8) Incidence and severity of the signs and symptoms of PTI. 9) Quality of life, severity of fatigue, motivation, energy, haemorrhage and bruising, and state of physical and mental health. Timepoints:Day 1 and weeks 1, 2 3 and 4 of each stage. ; Outcome name:1) Antiplatelet Antibodies: Peripheral blood samples for the identi | — |
Countries
Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Korea South, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Romania, Russian Federation, Slovakia, Slovenia, Spain, Sweden, Taiwan, Thailand, Tunisia, Ukraine, United Kindgdom, United States, Vietnam
Outcome results
None listed