EUCTR2007-006081-15-ES进行中（未招募）不适用
A multi-centre, single intravenous dose, exploratory dose-finding, open label trial on the safety and efficacy of Sym001 in the treatment of Immune Thrombocytopenic Purpura (ITP) in RhD positive, non-splenectomized adult subjects.Estudio abierto, multicéntrico, única dosis intravenosa, de búsqueda de dosis para determinar la seguridad y eficacia de Sym001 en el tratamiento de la púrpura trombocitopénica inmune (PTI) en pacientes no esplenectomizados y RhD positivos - N/A
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 55
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
- •1. Informed consent obtained before any trial-related procedures.
- •2. Age 18-75 inclusive.
- •3. Confirmed presence of thrombocytopenia with platelet count < 30,000/mm3 at the pre-dose visit. In each cohort a maximum of 3 subjects will be included with platelet counts < 10,000/mm3, in order to limit variability. The average of 2 individual pre-dose platelet counts taken on the dosing day and within > 1 hour interval between each other and both being < 30,000/mm3 will be used to confirm thrombocytopenia.
- •4. History of isolated ITP (thrombocytopenia with no known aetiology, blood smear showing normal appearing platelets or, if performed, a bone marrow showing adequate megacariocytosis and normal erythroid and myeloid morphology).
- •5. RhD-positive serology.
- •6. Previous treatment and response to first line therapy for ITP (corticosteroids, anti-D or IVIg), with response being defined as an increase in platelet count to
- •= 50,000/mm3.
- •7. female and of child-bearing potential, subject has a negative pregnancy test at screening.
- •8. If subject is a female of child-bearing potential, subject agrees to use a medically accepted form of contraception from the time of enrolment to completion of all follow-up trial visits.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Known clinical picture suggestive of other causes of thrombocytopenia, especially systemic lupus erythematosus, antiphospholipid syndrome, Evans syndrome, immunodeficiency states, lymphoproliferative disorders, liver disease, ingestion of drugs such as quinidine/quinine, heparin and sulfonamides and hereditary thrombocytopenia confirmed by relevant laboratory findings.
- •2. Suspected infection with HIV, hepatitis C, H. pylori unless corresponding laboratory tests are negative.
- •3. Clinical splenomegaly (the spleen should not be palpable at more than 1 finger breadth below the costal margin).
- •4. History of abnormal bone marrow examination.
- •5. At pre-dose visit: bleeding risk requiring emergency treatment for ITP or an ongoing haemorrhage requiring medical intervention.
- •6. History of anaphylaxis or hypersensitivity reactions following IVIg or anti-D treatment.
- •7. History of immune haemolytic anaemia.
- •8. Underlying haemolytic condition (e.g. reticulocyte count > 3%).
- •9. Planned surgery during the trial period.
- •10. Haemoglobin pre-dose value lower than 2g/dL below the lower limit of the laboratory normal range for gender and age.
- •11. History of splenectomy.
- •12. Known malignancy (except basocellular carcinoma).
- •13. Received investigational agent within 90 days prior to enrolment.
- •14. Positive DAT (direct Coombs-test) at screening unless subject has received treatment with anti-D products within 3 months prior to screening with prior negative DAT.
- •15. Known non-responders to most recent anti-D treatment (despite any initial response to treatment).
- •16. Any other current treatment for ITP except corticosteroids at doses up to 20 mg/day. (Acceptable if the dose has been constant for 2 weeks or more before trial drug administration).
- •17. Therapy with IVIg, anti-D or any other treatment of ITP within 4 weeks prior to enrolment.
- •18. Therapy with alkylating agents or rituximab within 8 weeks prior to enrolment
- •19. Any antithrombotic treatment (except acetyl salicylic acid at doses up to 150 mg daily) within 7 days prior to pre-dosing visit or planned during the trial.
- •20. PT/INR and aPTT out of normal range at the pre-dose visit
- •21. History of thrombosis or known thrombophilia.
- •22. Diseases other than ITP that may influence the result of the trial as judged by the Investigator.
- •23. Creatinine, alanine aminotransferase (ALT), alkaline phosphatase (ALP), and Albumin 25% or more outside normal range value (according to the local laboratory) at pre-dose visit.
- •24. Current or planned treatment with erythropoietin.
- •25. Subject is pregnant, breast feeding or intends to become pregnant.
研究者
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