CTRI/2011/11/002098暂停3 期
A Prospective, open-label, non-controlled, multicenter, phase III clinical study to evaluate the efficacy and safety of immunoglobulin intravenous (human) 10% (NewGam) inPrimary Immune Thrombocytopenia
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 95
- 试验地点
- 4
- 主要终点
- The primary objective of the study is to assess the efficacy of NewGam in correcting the platelet count.
研究概览
简要总结
Thisstudy is a Prospective, open-label, non-controlled, multicenter, phase IIIclinical study to evaluate the efficacy and safety of immunoglobulinintravenous (human) 10% (NewGam) in approximately 95 patients with PrimaryImmune Thrombocytopenia that will be conducted approximately 35 centers in India & in Europe.
ThePrimary outcome measures will be to assess the efficacy of NewGam in correctingthe platelet count. The secondary outcome will be to evaluate the safety ofNewGam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age of ≥18 years and ≤65 years.
- •Confirmed diagnosis of chronic primary ITP (threshold platelet count less than 100x109/L) of at least 12 months duration and fulfilling the following criteria: a) history and physical examination excluding other causes of thrombocytopenia b) pattern of bleeding associated with platelet disorders using the verbal rating scale according to Buchanan (2002) [8].
- •c) isolated thrombocytopenia in the blood count; apart from thrombocytopenia, the blood count is normal for the patient’s age, or if abnormal, readily explained d) peripheral blood smear consistent with ITP: thrombocytopenia with platelets of normal size or slightly larger than normal, with absence of platelet clumps and giant platelets; normal red and white blood cell morphology e) when any abnormal finding is present, additional diagnostic evaluation exclude other causes of thrombocytopenia.
- •Platelet count of ≤20x109/L with or without bleeding manifestations.
- •4.Freely given written informed consent from patient.
- •5.Women of childbearing potential must have a negative result on a pregnancy test (human chorionic gonadotropine [HCG]-based assay) and need to practice contraception using a method of proven reliability for the duration of the study.
- •Note:"In India as per the DCGI cap we will include patients from the age of 18 to 65 yrsâ€.
排除标准
- •1.Thrombocytopenia secondary to other diseases (such as Acquired Immunodeficiency Syndrome [AIDS] or systemic lupus erythematosus [SLE]) or drug-related thrombocytopenia.
- •2.Administration of intravenous immunoglobulin (IGIV), anti-D or thrombopoetin receptor agonists or other platelet enhancing drugs (incl.
- •immunosuppressive or other immunomodulatory drugs) within 3 weeks before enrollment, except for: a) long-term corticosteroid therapy when the dose has been stable during the preceding 3 weeks and no dosage change is planned until study Day
- •b) long-term azathioprine, cyclophosphamide or attenuated androgen therapy when the dose has been stable during the preceding 3 months and no dosage change is planned until study Day
- •3.Unresponsive to previous treatment with IGIV or anti-D immunoglobulin.
- •4.Experimental treatment (e.g. Rituximab) within 3 months before enrollment.
- •5.Splenectomy in the previous 4 weeks or planned splenectomy throughout the study period.
- •6.Subject with Evans syndrome (autoimmune thrombocytopenia and autoimmune hemolysis).
- •7.Known or suspected human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection 8.Live viral vaccination within the last two months before study entry.
- •9.Emergency operation.
- •Severe liver or kidney disease (alanine aminotransferase [ALAT] 3x > upper limit of normal, creatinine >120 µmol/L).
- •Congestive heart failure New York Heart Association (NYHA) class III or IV.
- •Non-controlled arterial hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >90 mmHg).
- •History of hypersensitivity to blood or plasma derived products, or any component of the investigational product.
- •Known immunoglobulin A (IgA) deficiency and antibodies against IgA.
- •History of, or suspected alcohol or drug abuse.
- •Pregnant or nursing women.
- •Unable or unwilling to comply with the study protocol.
- •Participating in another interventional clinical study and receiving investigational medicinal product within three months before study entry.
- •Patients with body mass index ≥ 30kg /m2
- •Patients with risk factors(i) for thromboembolic events in whom the risks outweigh the potential benefit of NewGam treatment (i) Such as obesity,advanced age , hypertension, diabetes, a history of atheroschlerosis/vascular disease or thrombotic events , hyperlipidaemia, multiple cardiovascular risk factors, acquired or inherited thrombophilic disorders, prolonged periods of immobilization, severe hypvoleamia, central venous catheterization, active malignancy and/or known or suspected hyperviscosity.
结局指标
主要结局
The primary objective of the study is to assess the efficacy of NewGam in correcting the platelet count.
时间窗: Day 8
次要结局
- The secondary objective of the study is to evaluate the safety and the efficacy of NewGam.(Efficacy outcome- Day 22)
研究者
研究点 (4)
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