CTRI/2010/091/003049已完成2 期
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. - SYM-001
Symphogen AS0 个研究点目标入组 66 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Informed consent obtained before any trial-related procedures.
- •2. Age > 18.
- •3. Confirmed presence of thrombocytopenia with platelet count < 30,000/mm3 at the pre-dose visit. In each cohort < 200 μg/kg a maximum of 3 subjects will be included with platelet counts < 10,000/mm3, and in cohorts > 200 μg/kg a maximum of 1 subject with platelet counts < 10,000/mm3 will be included in order to limit variability. Two 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 thrombopoïesis 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 >=30,000/mm3.
- •7. If 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 (at screening) to completion of all follow-up trial visits.
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 (except ITP-typical megacaryocytosis).
- •5. At pre-dose visit: an ongoing haemorrhage corresponding to a grade 3 or 4 on the WHO bleeding scale.
- •6. History of anaphylaxis or hypersensitivity reactions following anti-D treatment.
- •7. Current immune haemolytic anaemia.
- •8. Underlying haemolytic condition (e.g. reticulocyte count > 3%).
- •9. Planned surgery during the 15 days post dosing.
- •10. Haemoglobin pre-dose value lower than 2.0 g/dL below the lower limit of the laboratory normal range for gender and age.
- •11. History of splenectomy.
- •12. Known current malignancy (except basal cell carcinoma).
- •13. Received other investigational agent within 3 months prior to enrolment.
- •14. Positive DAT (direct Coombs-test) at screening unless subject has received treatment with IVIg or 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 (Prednisone or Dexamethasone) at doses equivalent to ≤30 mg prednisone/day if the daily dose has been constant for 2 weeks or more before trial drug administration.
- •17. Therapy with IVIg within 2 weeks prior to enrolment or with anti-D or any other treatment of ITP within 4 weeks prior to enrolment.
- •18. Therapy with tranexamic acid, alkylating agents or any anti-CD20 antibodies 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 venous or arterial thrombosis or known thrombophilia.
- •22. Diseases other than ITP that may influence the result of the trial as judged by the Investigator.
- •23. Creatinine 25% or more above normal range value, alanine aminotransferase (ALT) and alkaline phosphatase (ALP) 100% above normal range value, and albumin 25% or more below normal range value.
- •24. Current or planned treatment with erythropoietin.
- •25. Subject is pregnant, breast feeding or intends to become pregnant
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