NCT00782106已完成1 期
Phase 1/2 Determination of the Dose of Recominant Human Hyaluronidase (rHuPH20) Required Enabling Up to 600 mg/kg Bodyweight of IGIV, 10% to be Administered Subcutaneously in a Single Infusion Site in Subjects With Primary Immunodeficiency (PID)
Baxalta now part of Shire3 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2006年12月4日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 3
- 主要终点
- Ability to administer, after priming with recombinant human hyaluronidase, at least one half of a 4-week dose (minimum of 200 mg/kg) of IgG in a single infusion site, via the subcutaneous route, with no more than mild local adverse drug reactions.
研究概览
简要总结
The purpose of the study is to determine the feasibility of infusing a full 4-week dose of Immune Globulin Intravenous (Human), 10% in a single subcutaneous site and the amount of recombinant human hyaluronidase needed to infuse that dose with no more than mild local adverse drug reactions.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent from either the subject or the subject's legally acceptable representative
- •Diagnosis of a PID disorder as defined by World Health Organization criteria1 for which the subject had been receiving a regimen of weekly or biweekly (every-other-week) subcutaneous IgG infusions or IGIV infusions every 21 to 28 days over a period of at least 8 weeks pre-study at an equivalent of a 4-week dose of 300 to 800 mg/kg bodyweight
- •Adults/adolescents aged 16 years and older)
- •For female subjects of child-bearing age: negative urine pregnancy test result at study entry and agreement to employ adequate birth control measures for the duration of the study
排除标准
- •Subjects positive at enrollment for one or more of the following: HBsAg, PCR for HCV, PCR for HIV Type 1
- •Subjects with levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal for the testing laboratory
- •Subjects with neutropenia (defined as an absolute neutrophil count [ANC] <= 500/mm3).
- •Subjects with serum creatinine levels greater than 1.5 times the upper limit of normal for age and gender
- •Subjects with current history of malignancy
- •Subjects with a history of thrombotic episodes (deep vein thrombosis, myocardial infarction, cerebrovascular accident)
- •Subjects with abnormal protein loss (protein losing enteropathy, nephritic syndrome, severe lung disease)
- •Subjects with anemia that in the opinion of the investigator precluded phlebotomy for laboratory studies
- •Subjects who had been exposed to any blood or blood product other than an intravenous immunoglobulin (IGIV), SC immunoglobulin (SCIG), immune serum globulin (ISG) preparations, or albumin within the 6 months prior to study entry.
- •Subjects with an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV, SCIG and/or ISG infusions
- •Subjects with IgA deficiency and known anti IgA antibodies
- •Subjects who had received antibiotic therapy for the treatment of infection within 7 days prior to enrollment
- •Subjects who had participated in another clinical study involving an investigational product or device within 28 days prior to study entry
- •Subjects with inability or unwillingness to meet all the requirements of this study
- •If female, pregnancy or lactation at time of study entry
研究组 & 干预措施
1
Experimental
Tolerability of subcutaneous infusions
干预措施: Recombinant human hyaluronidase + immune globulin intravenous (Biological)
2
Experimental
Tolerability of subcutaneous infusions and pharmacokinetics
干预措施: Recombinant human hyaluronidase + immune globulin intravenous (Biological)
结局指标
主要结局
Ability to administer, after priming with recombinant human hyaluronidase, at least one half of a 4-week dose (minimum of 200 mg/kg) of IgG in a single infusion site, via the subcutaneous route, with no more than mild local adverse drug reactions.
时间窗: 72 hours
次要结局
未报告次要终点
研究者
研究点 (3)
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