CTRI/2010/091/000016已完成3 期
A Phase III, Multicenter, Open-Label Study To Evaluate the Efficacy and Safety of GAMMAPLEX® in Chronic Idiopathic Thrombocytopenic Purpura
Bio Products Laboratory0 个研究点目标入组 31 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
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) Males and females aged between 18 and 70 years. 2) Confirmed diagnosis of chronic ITP of at least 6 months
- •duration. 3) Platelet count ≤20 x 109/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. 8) The subject has signed an
- •informed consent form (subjects must be at least 18 years old), and/or the subject?s legal guardian has signed the
- •informed consent form if indicated. 9) If a subject is a female of child-bearing potential, she must have a negative
- •result on a urine-based HCG pregnancy test. 10) If a subject is a female who is or becomes sexually active, she
- •must practice contraception by using a method of proven reliability for the duration of the study.
排除标准
- •1) The subject has a history of any severe or anaphylactic reaction to blood or any bloodderived
- •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) < 1 x 109/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 anemic (hemoglobin
- •<10 g/dL) at screening. 19) The subject is unlikely to adhere to the protocol requirements of the study or is likely
- •to be uncooperative.
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