NCT00504075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 Laboratory58 个研究点 分布在 3 个国家目标入组 35 人开始时间: 2007年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 58
- 主要终点
- The Number of Subjects With Chronic ITP Treated With Gammaplex Whose Platelet Count Reached a Threshold of 50 x 10^9/L.
研究概览
简要总结
To determine if GAMMAPLEX raises the platelet count of subjects with chronic ITP to a threshold of 50 x 109/L, similar to that of published response >60%. Also to assess the safety of GAMMAPLEX and determine if platelet counts are maintained at 50 x 109/L in subjects with chronic ITP for.
详细描述
The primary objective is to determine if BPL's GAMMAPLEX raises the platelet count of subjects with chronic ITP to a threshold of 50 x 109/L, similar to that of published response >60%. The secondary objectives are: 1) to determine the safety of GAMMAPLEX at the dosage used in this study. 2) to determine if GAMMAPLEX maintains platelet counts of ³ 50 x 109/L in subjects with chronic ITP for a period of time similar to that of a published data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
- •The dose of corticosteriod or other immunosuppressant should have remained constant until Day
- •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
- •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 Day
- •Received an IGIV preparation within 1 month prior to Day
- •Were currently receiving, or has received, any investigational agent within the 1 month prior to Day
- •Received any blood, blood product, or blood derivative within the 1 month prior to Day
- •Received Rituximab within the 3 months before Day
- •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
- •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.
研究组 & 干预措施
Gammaplex (intravenous immunoglobulin)
Experimental
干预措施: Gammaplex, intravenous immunoglobulin (Biological)
结局指标
主要结局
The Number of Subjects With Chronic ITP Treated With Gammaplex Whose Platelet Count Reached a Threshold of 50 x 10^9/L.
时间窗: 9 days
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.
次要结局
- Duration of Time That the Platelet Count of Subjects With Chronic ITP Treated With Gammaplex Remained ≥ 50 x 10^9/L.(Days 1, 2, 3, 5, 9, 14, 21, 32.)
- The Safety of GAMMAPLEX at the Dosage Used in This Study.(AEs were documented from the date the informed consent form was signed until the End of Study visit on Day 90.)
研究者
研究点 (58)
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