IGIV-C 10% Rapid Infusion Trial in Primary Immune Deficient Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 13
- 主要终点
- Infusion related adverse events
研究概览
简要总结
The objective of this study is to determine if the safety and tolerability of Immune Globulin Intravenous (Human), 10% caprylate/chromatography (IGIV-C)purified is similar when infused at two different infusion rates. The primary objective is to compare the incidence and severity of all infusion related adverse events when IGIV-C, 10% is administered at a rate of 0.14 mL/kg/min compared to a rate of 0.08 mL/kg/min after a single daily infusion.
详细描述
This is a prospective, single blind, randomized, multi-center cross-over trial in patients with Primary Immune Deficiency. Patients with a confirmed diagnosis of primary Immune Deficiency will be treated with two daily infusions given 3-4 weeks apart at the fixed individual IGIV dose regimen (400-600 mg/kg) established prior to entry into the study. Any subject with an established dose in the range of 200-399 mg/kg will be assigned to receive 400 mg/kg during the course of the study during the same dosing schedule established prior to entry into the study.
After a screening period lasting not more than four weeks, patients will be randomized into one of two cross-over groups. Patients randomized to Group 1 will receive their first IGIV-C, 10% dose at a rate of 0.08 mL/kg/min and their second infusion at a rate of 0.14 mL/kg/min, whereas patients randomized to Group 2 will receive IGIV-C, 10% at a rate of 0.14 mL/kg/min on the first infusion day and then 0.08 mL/kg/min on the second infusion day. All patients just prior to each IGIV-C, 10% infusion will receive the same volume of 5% dextrose as calculated for their IGIV-C, 10% infusion and given at a target rate according to the schema below.
Group 1:
- Infusion #1 (Week 0)Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min)
- Infusion #2 (Week 3-4)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min)
Group 2:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of primary immune deficiency and medical records available for retrospective review for at least 3 months prior to entry into the trial
- •Signed an informed consent written informed consent prior to initiation of any study related procedures
- •Receiving regular infusions of IGIV at a fixed interval and dosage (in the range of 200-600 mg/kg given every 3-4 weeks) for at least three months prior to entry into the trial. Patients who are currently receiving less than 400 mg/kg are eligible for this trial and will be at the time of study enrollment be treated at 400 mg/kg
排除标准
- •History or suspicion of significant allergic reaction to intravenous immune globulin, and/or blood products
- •Documented history of selective IgA deficiency (serum level <5.0 mg/dL) and known antibodies to IgA
- •Isolated IgG subclass deficiency with a normal total serum IgG level
- •Other conditions which may interfere with the trial, include the patients demeanor or mental ability to follow instruction.
- •Pretreatment with anti-pyretics or anti-histamines
- •Congestive heart failure (New York Heart Association stage greater than Class II)
- •Renal insufficiency (creatinine >2.5 mg/dL)
- •Conditions whose symptoms and effects could alter protein catabolism and/or IgG utilization (e.g. protein-losing enteropathies, nephrotic syndrome)
- •Pretreatment routinely required to control/ameliorate IGIV infusion-related adverse events (AEs)
- •Any patient who requires IGIV dosing more frequently than every 3 weeks to maintain adequate trough levels
- •Women of child bearing potential who do not practice adequate contraception (i.e. chemical or mechanical methods) and pregnant or lactating females
研究组 & 干预措施
Group 1
Infusion #1 (Week 0)Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min) ; Infusion #2 (Week 3-4)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min)
干预措施: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified (Drug)
Group 1
Infusion #1 (Week 0)Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min) ; Infusion #2 (Week 3-4)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min)
干预措施: Dextrose, 5% in Water (Drug)
Group 2
Infusion #1 (Week 0)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min); Infusion #2 Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min)
干预措施: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified (Drug)
Group 2
Infusion #1 (Week 0)Dextrose (0.08 mL/kg/min), then IGIV-C, 10% (0.14 mL/kg/min); Infusion #2 Dextrose (0.14 mL/kg/min), then IGIV-C, 10% (0.08 mL/kg/min)
干预措施: Dextrose, 5% in Water (Drug)
结局指标
主要结局
Infusion related adverse events
时间窗: within 72 hours after infusion
次要结局
- All adverse events(within 72 hours after infusion)