EUCTR2011-005586-21-Outside-EU/EEA进行中（未招募）不适用
A Phase III, Multicenter, Open-Label Study To Evaluate the Efficacy and Safety of GAMMAPLEX® in Chronic Idiopathic Thrombocytopenic Purpura - n/a
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 35
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) Males and females aged between 18 and 70 years.
- •2) Confirmed diagnosis of chronic ITP of at least 6 months duration.
- •3) Platelet count <=20x10^9/L at enrollment.
- •4) Absence of other conditions that, in the opinion of the investigator, could cause thrombocytopenia.
- •5) If subjects are currently being treated with corticosteroids the treatment regimen/dose must have been stable (for a minimum of 2 weeks before Day 1 infusion). However, subjects must remain on a stable treatment regimen. If there is any intent to alter the corticosteroid treatment regimen (e.g., tapering of corticosteroids) before Day 10, subjects may not be included in the study.
- •6) If subjects are currently being treated with cyclophosphamide, azathioprine or attenuated androgens, the treatment regimen and dose must have been stable for a minimum of 2 months before infusion on Day 1. However, if there is any intent to alter the treatment regimen before Day 10, subjects may not be included in the study.
- •7) Splenectomized subjects and both Rh(D)+ and Rh(D)- subjects may be included.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 3
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 29
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •1) The subject has a history of any severe or anaphylactic reaction to blood or any blood-derived product, or any severe reaction to IGIV or any other IgG preparation.
- •2) The subject is known to be intolerant to any component of the investigational product.
- •3) The subject has received any live virus vaccine within the last 3 months prior to Day 1.
- •4) The subject has received an IGIV preparation within 1 month prior to Day 1.
- •5) The subject is currently receiving, or has received, any investigational agent within the 1 month prior to Day 1.
- •6) The subject has received any blood, blood product, or blood derivative within the 1 month prior to Day 1.
- •7) The subject has received Rituximab within the 3 months before Day 1.
- •8) The subject is pregnant or is nursing.
- •9) The subject is positive for any of the following at screening: HBsAg, NAT for HCV, NAT for HIV, Antibodies to HCV or HIV 1 or 2.
- •10) The subject, at screening, has levels greater than 2.5 times the upper limit of normal, as defined by the central laboratory, of alanine aminotransferase or aspartate aminotransferase.
- •11) The subject has a severe renal impairment (defined as serum creatinine greater than 2 times the upper limit of normal or BUN greater than 2.5 times the upper limit of normal for the range of the laboratory doing the analysis); the subject is on dialysis; the subject has a history of acute renal failure.
- •12) The subject is known to have abused alcohol, opiates, psychotropic agents, or other chemicals or drugs within the past 12 months.
- •13) The subject has a history of deep vein thrombosis (DVT) or thrombotic complications of IGIV therapy.
- •14 The subject has any history or sign of hyperviscosity, transient ischemic attack (TIA), stroke, other thromboembolic event, or unstable angina.
- •15) The subject suffers from any acute or chronic medical conditions (e.g., renal disease or predisposing conditions for renal disease, coronary artery disease, or protein losing enteropathy) that, in the opinion of the investigator, may interfere with the conduct of the study.
- •16) The subject has an acquired medical condition, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (defined as an absolute neutrophil count (ANC) < 1x10^9/L).
- •17) The subject has non-controlled arterial hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg).
- •18) The subject is anaemic (haemoglobin <10 g/dL) at screening.
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