EUCTR2011-001354-29-ES进行中（未招募）1 期
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 38 人开始时间: 2012年7月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 38
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 clinically
- •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:
- •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 (systolic blood pressure > or = to160 mmHg and diastolic blood pressure > 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 virus, hepatitis C virus, or human immunodeficiency virus.
- •6. Treatment that could induce thrombocytopenia within 15 days prior to inclusion.
- •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 (EMA/CHMP/BPWP/94033/2007 rev.2),
- •- 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 weeks,
- •- 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 or planned surgery 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 (i.e. haemophilia).
- •16. Administration of another investigational medicinal product within the last month.
- •17. Any serious medical condition that would interfere with the clinical assessment of I10E or prevent the patient to comply with the protocol requirements.
- •18. Pregnant with positive results on a urine pregnancy test or breastfeeding woman, or woman of childbearing potential without effective contraception (effective contraception are: injectable, patch or combined
- •oral estro-progestative or progestative contraceptives, intra-uterine devices of type 'copper T' and levonorgest releasing IU systems, depot intramuscular medroxyprogesteron, subcutaneous implants of
- •progestative contraceptive implants, barrier methods of contrac
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