A Study to Find How Safe and Effective GAMMAPLEX® is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP)
A Phase III, Multicenter, Open-Label Study To Evaluate the Efficacy and Safety of GAMMAPLEX® in Chronic Idiopathic Thrombocytopenic Purpura
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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New Delhi、印度、110060
- Sir Ganga Ram Hospital
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Andhra Pradesh
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Hyderabad、Andhra Pradesh、印度、500003
- Apollo Hospitals
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Hyderabad、Andhra Pradesh、印度、500054
- Mahavir Hospital
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Suryarao pet, Vijayawada、Andhra Pradesh、印度、520002
- City Cancer Centre,
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Bangalore
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Karnataka、Bangalore、印度、560054
- M. S Ramaiah Hospital
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Gujarat
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Ahmedabad、Gujarat、印度、380009
- Vedanta
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Ahmedabad、Gujarat、印度、380061
- Gurukrupa Hospital
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Gokal Nagar, Karamsad、Gujarat、印度、388325
- M S Patel Cancer Centre, Shree Krishna Hospital
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Karnataka
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Bangalore、Karnataka、印度、560017
- Manipal Hospital
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Mangalore、Karnataka、印度、575002
- Father Muller Medical College Hospital
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Mangalore、Karnataka、印度、5750003
- Vinaya Hospital & research Centre
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Mangalore、Karnataka、印度、575001
- Kasturba Medical College, Manipal Acunova KMC Research Centre
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Maharashtra
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Pune、Maharashtra、印度、411004
- Deenanath Mangeshkar Hospital
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Rajasthan
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Jaipur、Rajasthan、印度、300201
- S.K. Soni Hospital Sect 5
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Florida
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Orange City、Florida、美国、32763
- Mid Florida Hematology & Oncology
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Illinois
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Chicago、Illinois、美国、60612
- Rush University Medical Center
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Maryland
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Bethesda、Maryland、美国、20817
- Center for Cancer & Blood Disorders
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New York
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New York、New York、美国、10021
- New York Hospital / Cornell University, Division of Pediatrics
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Stony Brook、New York、美国、11794-8111
- Department of Pediatrics, SUNY at Stony Brook
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Oregon
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Portland、Oregon、美国、97239
- Oregon Health & Science University
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Texas
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San Antonio、Texas、美国、78229
- Cancer Care Centers of South Texas
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Buenos Aires、阿根廷、C1280AEB
- Hospital Británico
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Buenos Aires、阿根廷、C1122AAL
- I. A. D. T. (Instituto Argentino de Diagnóstico y Tratamiento)
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Buenos Aires、阿根廷、C1431FWO
- Centro de Educación Médica e Investigaciones Clinicas Dr. Norberto Quirno (CEMIC)
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Cordoba、阿根廷、X5016KEH
- Hospital Privado de Cordoba
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Corrientes、阿根廷
- J.R. Vidal Hospital
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San Juan、阿根廷、5400
- CER San Juan
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Buenos Aires
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Capital Federal、Buenos Aires、阿根廷、C1437JCP
- Hospital Churruca
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La Plata、Buenos Aires、阿根廷、B1900AXU
- Hospital Italiano de La Plata
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Sante Fe
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Rosario、Sante Fe、阿根廷、S2000JKR
- Instituto de Diagnóstico Hematológico Ambulatorio (IDHEA)
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Males and females aged between 18 and 70 years.
- Confirmed diagnosis of chronic ITP of at least 6 months duration.
- Platelet count of less than or equal to 20 x 10 9/L at enrollment.
- Absence of other conditions that, in the opinion of the investigator, could cause thrombocytopenia.
- If subjects were treated with corticosteroids the treatment regimen/dose must have been stable (for a minimum of 2 weeks before screening). The dose of corticosteriod or other immunosuppressant should have remained constant until Day 32. 6) If subjects were being treated with cyclophosphamide, azathioprine or attenuated androgens, the treatment regimen and dose must have been stable for a minimum of 2 months before Day 1. The dose of corticosteriod or other immunosuppressant should have remained constant until Day 32. 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.
Exclusion Criteria:
- 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.
- Intolerance to any component of the investigational product.
- Received any live virus vaccine within the last 3 months prior to Day1.
- Received an IGIV preparation within 1 month prior to Day 1.
- Were currently receiving, or has received, any investigational agent within the 1 month prior to Day 1.
- Received any blood, blood product, or blood derivative within the 1 month prior to Day 1.
- Received Rituximab within the 3 months before Day 1.
- Pregnant or nursing.
- Tested positive for any of the following at screening: HBsAg, NAT for HCV, NAT for HIV, Antibodies to HCV or HIV 1 or 2.
- Had levels greater than 2.5 times the upper limit of normal at screening, as defined by the central laboratory, of alanine aminotransferase or aspartate aminotransferase.
- Had 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); on dialysis; a history of acute renal failure.
- Known to have abused alcohol, opiates, psychotropic agents, or other chemicals or drugs within the past 12 months.
- History of deep vein thrombosis (DVT) or thrombotic complications of IGIV therapy.
- Any history or sign of hyperviscosity, transient ischemic attack (TIA), stroke, other thromboembolic event, or unstable angina.
- Suffered 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.
- 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).
- Non-controlled arterial hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg).
- Anemic (hemoglobin <10 g/dL) at screening.
- Unlikely to adhere to the protocol requirements of the study or is likely to be uncooperative.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Gammaplex (intravenous immunoglobulin)
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Dosage form: Gammaplex® is a sterile liquid of 5 % w/v normal immunoglobulin. Gammaplex® contains 5 g/100 mL of human normal immunoglobulin (i.e. 50 g/L, of which virtually 100% is IgG). The first course of GAMMAPLEX will be administered as an intravenous infusion of 1 g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen may be administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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The Number of Subjects With Chronic ITP Treated With Gammaplex Whose Platelet Count Reached a Threshold of 50 x 10^9/L.
大体时间:9 days
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The number of subjects with chronic ITP treated following treatment with Gammaplex who attained a platelet count of ≥ 50 x 10^9/L by Day 9.
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9 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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The Safety of GAMMAPLEX at the Dosage Used in This Study.
大体时间:AEs were documented from the date the informed consent form was signed until the End of Study visit on Day 90.
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The safety variables used to assess safety were the following:
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AEs were documented from the date the informed consent form was signed until the End of Study visit on Day 90.
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Duration of Time That the Platelet Count of Subjects With Chronic ITP Treated With Gammaplex Remained ≥ 50 x 10^9/L.
大体时间:Days 1, 2, 3, 5, 9, 14, 21, 32.
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Blood samples were collected to measure platelet counts and the duration of time for which the platelet count remained ≥50 x 10^9/L was measured.
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Days 1, 2, 3, 5, 9, 14, 21, 32.
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合作者和调查者
调查人员
- 首席研究员:Tim J Aldwinckle, MD、Bio Products Laboratory
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- GMX02
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Gammaplex, intravenous immunoglobulin的临床试验
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Bio Products Laboratory完全的原发性免疫缺陷 | Wiskott-Aldrich 综合症 | 低丙种球蛋白血症 | 常见变异性低丙种球蛋白血症 | X连锁低丙种球蛋白血症 | Hyper-IgM 免疫缺陷美国