Clinical Study to Evaluate the Efficacy, Safety and Kinetics of Octagam 10% for Replacement Therapy in Primary Immunodeficiency Diseases
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Octapharma
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
Octagam is a human normal immunoglobulin (IGIV) solution for intravenous administration. Octagam 5% is currently registered in more than 60 countries. This study will evaluate the efficacy, safety and the kinetics of Octagam 10% for replacement therapy in primary immunodeficiency diseases.
详细描述
The primary objective of the study is to investigate the safety of Octagam 10% in replacement therapy in PID and to compare the pharmacokinetic profile of Octagam 10% with that of the previously used Octagam 5%.
The secondary objective is to investigate the efficacy of Octagam 10% in replacement therapy in PID by monitoring the rate of occurence of serious bacterial infections, the rate of other infections, the trough (pre-next-dose) levels of total serum IgG and IgG subclasses (IgG1, IgG2, IgG3 and IgG4), the trough (pre-next-dose) levels of selected antigen specific antibodies, the use of antibiotics, the rate of absence from school/ work, and the number of days in hospital.
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
- 2 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of primary immunodeficiency (acc. WHO)
- •Previous treatment with commercial Octagam 5% every 3-4 weeks for at least 6 infusions intervals
- •Documented IgG trough levels of the two previous infusions before enrollment with a value of at least 5.5 g/L for both
排除标准
- •Acute infection requiring intravenous antibiotic treatment within two weeks before screening
- •Exposure to blood or any blood product or derivative other than commercially available Octagam 5%, within the past 3 months
- •History of hypersensitivity to blood or plasma derived products
- •Requirement of any routine premedication for IGIV treatment
- •History of congenital impairment of pulmonary function
- •Severe liver function impairment
- •Severe renal function impairment or predisposition for acute renal failure
- •History of autoimmune haemolytic anaemia
- •History of diabetes mellitus
- •Congestive heart failure NYHA III or IV
- •Non-controlled arterial hypertension
- •History of DVT or thrombotic complications with IGIV treatment
- •Known infection with HIV, HCV or HBV
- •Treatment with steroids, immunosuppressive or immunomodulatory drugs
- •Planned vaccination during study period
- •Pregnant or nursing woman
研究组 & 干预措施
Octagam 10%
干预措施: Octagam 10% (Drug)
结局指标
主要结局
Adverse Events
时间窗: During infusion or within 72 hours after end of infusion
Occurrence of Adverse Events
Pharmacokinetics of Serum Total IgG and IgG Subclasses (IgG1, IgG2, IgG3 and IgG4) and Pharmacokinetics of Specific Antibodies Against Defined Infectious Agents Comparing Octagam 5% Treatment With Octagam 10% Treatment
时间窗: after 6 months of treatment
Pharmacokinetics of serum total IgG and IgG subclasses (IgG1, IgG2, IgG3 and IgG4) and pharmacokinetics of specific antibodies against defined infectious agents comparing Octagam 5% treatment with Octagam 10% treatment
次要结局
- Pre-next-dose Levels of Serum Total IgG(before each treatment)
- Pre-next-dose Levels of IgG Subclasses (IgG1, IgG2, IgG3, IgG4) and Pre-next-dose Levels of Specific Antibodies Against Defined Infectious Agents(before treatement 10 and 13 (of 13 or 17 treatments) and at the end)
- Therapeutic Efficacy (Number of Infections, Number of Missed Days at School/ Work, Number of Hospitalisation Days, and Use of Antibiotics)(12 months)
- Vital Signs(during each treatment)
- Laboratory Parameters (Hematology, Clinical Chemistry, Direct Coombs Test and Urin Analysis)(at each treatment date (every three to four weeks))
- Assessment of Viral Safety(Every three months)