EUCTR2014-000608-90-IT进行中（未招募）1 期
Eltrombopag for inherited thrombocytopenias.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients with the following forms of inherited thrombocytopenias will be considered for enrolment:
- •- MYH9-related disorders (OMIM 155100, 605249, 153640, 153650)
- •- Bernard-Soulier Syndrome (OMIM 231200) deriving from monoallelic mutations (at variance with biallelic classical BSS, monoallelic form does not present defective platelet function)
- •- Wiskott-Aldrich syndrome (OMIM 301000).
- •- X-linked thrombocytopenia (OMIM 313900).
- •- X-linked thrombocytopenia with thalassemia (OMIM 314050).
- •- Dyserythropoietic anemia with thrombocytopenia (OMIM 300367).
- •- ITGA2B/ITGB3-related thrombocytopenia (OMIM not available).
- •- ANKRD26-related thrombocytopenia (OMIM 188000).
- •- TUBB1-related thrombocytopenia (OMIM not available)
- •- ACTN1-related thrombocytopenia (OMIM not available)
- •- GFI1B-related thrombocytopenia (OMIM not available)
- •Patients will have to fulfill all the following criteria:
- •- Age = 16 years and = 70 years
- •- Average platelet count during the previous year less than 80 x109/L
- •- Written informed consent
- •Patients with clinically relevant chronic or recurrent bleedings at baseline (grade 2-4 of the WHO bleeding scale) who: (i) completed the phase 1 without severe side effects and (ii) obtained reduction or remission of bleeding by Eltrombopag administration.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 3
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 16
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Phases 1 and 2
- •-Hypersensitivity to Eltrombopag or one of the excipients.
- •- History of thromboembolic events.
- •- Treatment with anti-platelet drugs or other drugs affecting platelet function and/or with anticoagulants.
- •- Concurrent diseases or conditions that significantly increase the risk of thromboembolic events, including: malignancies, congestive heart failure (NYHA Grade III/IV), atrial fibrillation or other arrhythmias that predispose to thromboembolic events, known hereditary factors predisposing to venous thromboembolism (factor V mutations, factor II mutations, deficiency of antithrombin III, or protein C, or protein S), antiphospholipid syndrome, hormone replacement therapy and systemic contraception containing estrogen, severe obesity, severe hypertension not controlled by treatment, heavy smoking, diabetes mellitus not controlled by therapy or complicated, severe dislipidemia, haemoglobinopathies increasing the risk of thrombotic events, such as sickle cell anemia or thalassemia major.
- •- Moderate to severe liver failure (Child-Pugh score = 5).
- •- Altered renal function as defined by creatinine = 2 mg/dL
- •- Previous or concurrent clonal disorders of the myeloid series (acute myeloid leukemias and myelodysplastic syndromes).
- •- Females who are pregnant or nursing (a negative pregnancy test is required before enrolment of fertile women).
- •- Formal refusal of any recommendations for a safe contraception.
- •- Alcohol or drug addiction.
- •- Any other disease or condition that by the advice of the responsible physician would make the treatment dangerous for the patient or would make the patient ineligible for this study, including physical, psychiatric, social and behavioral problems.
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