EUCTR2011-001354-29-IT进行中（未招募）不适用
An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP)
FB BIOTECHNOLOGIES0 个研究点目标入组 40 人开始时间: 2012年3月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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. Both genders
- •2. Age between 18 to 65 year old
- •3. Chronic Primary ITP
- •- ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria
- •adopting the new consensus terminology proposed by an international
- •working group (Rodeghiero et al, 2009):
- •? Isolated thrombocytopenia diagnosed with platelet count
- •<100 x 10exp9/l and no abnormality of cells of other haematological
- •lineage and,
- •? Normal bone marrow (if available), or history of response to an
- •ITP treatment (corticosteroids, IVIg, anti-D) and,
- •? Failure to find any other causes of thrombocytopenia.
- •- Chronic ITP with bleeding(s) or an increased risk of bleeding:
- •? More than 12 months from diagnosis of ITP and,? Platelet counts < 30 x 10exp9/l at the time of inclusion.
- •Note: Refractory ITP may be included and is defined by the failure to
- •achieve a response or by the loss of response after splenectomy and the
- •need of treatment (s) to minimize the risk of bleeding considered as
- •significant by the investigator.
- •4. Written informed consent.
- •5. Patient is covered by health care insurance system.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Known hypersensitivity to the active substance or to any of the
- •excipients.
- •2. Patient with IgA deficiency except if the absence of anti IgA
- •antibodies is documented.
- •3. History of cardiac insufficiency (NYHA III/IV), cardiomyopathy,
- •congestive heart failure, or severe hypertension (sbp> or = to160 mmHg and dbp> or = to 100 mmHg).
- •4. History of thrombotic episodes (including deep vein thrombosis,
- •myocardial infarction, cerebrovascular accident, pulmonary embolism)
- •within the last 12 months.
- •5. Patient known to be infected with hepatitis B, C virus,
- •or human immunodeficiency virus.
- •6. Treatment that could induce thrombocytopenia within 15 days prior to
- •7. Recent previous treatment, the action of which may interfere with the
- •assessment of the investigational medicinal product:
- •- Initiation of corticosteroids or regular increase in the steroid dose
- •within the last 4 weeks,
- •- IVIg within the last 4 weeks,
- •- Anti-D within the last 4 weeks,
- •- Cyclosporin A within 4 weeks,
- •- Immunomodulator (as vincristin, vinblastin) within the last month,
- •- Immunosuppressor (azathioprine, cyclophosphamide) within the last 4
- •- Anti-CD20 (rituximab) within the last 4 months,
- •- Antigonadotropin Hormone (danazol) within the last 6 months,
- •- Thrombopoietin receptors agonist (eltrombopag, romiplostim) within
- •the last 4 weeks,
- •8. Splenectomy required during the study period or within the two
- •previous months.
- •9. Severe haemorrhagic syndrome whether life-threatening or not, such
- •as intracranial haemorrhage, gastrointestinal haemorrhage,
- •gynaecological
- •haemorrhage with deglobulisation of more than 2g/dL or major
- •cutaneous-mucosal haemorrhagic syndrome.
- •10. Severe bleeding requiring platelets transfusion at time of inclusion,
- •or whole blood transfusion.
- •11. Plasma exchange 4 weeks before inclusion.
- •12. Concomitant disease that may induce a secondary immune
- •thrombocytopenia, as:
- •- Clinical active systemic lupus erythematous with more than 4 American
- •College of Rheumatology criteria,
- •- Lymphoproliferative disease or active malignant condition requiring
- •antineoplastic or cytotoxic treatment.
- •13. Known hepatic disorder including total bilirubin > 2 x upper limit of
- •normal range, alanine aminotransferase (ALT) or aspartate amino
- •transferase (AST) > 3 x upper limit of normal range.
- •14. Known chronic renal insufficiency or creatinine clearance values < 80
- •ml/min in adult patients (Modified Diet in Renal Disease calculation).
- •15. Medical history of haemolysis or haemolytic anaemia during prior
- •IVIg therapy or any other concomitant disease of clotting system.
- •16. Administration of another investigational medicinal product within the last month.
- •17. Any serious medical condition that would interfere with the clinical
- 另有 11 项未显示
研究者
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