EUCTR2007-002611-27-GB进行中（未招募）1 期
Clinical study to evaluate the efficacy, safety and kinetics of Octagam® 10% for replacement therapy in Primary Immunodeficiency Diseases (PID) - NA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Age of = 2 years and = 75 years.
- •For minor patients, above a minimum weight based on the amount of blood
- •required for testing: per individual, the trial-related blood loss (including any
- •losses in the manoeuvre) should not exceed 3% of the total blood volume during a
- •period of four weeks and should not exceed 1% at any single time (the total
- •volume of blood is estimated at 80 ml/kg body weight).
- •Confirmed diagnosis of primary immunodeficiency as stated by the World Health
- •Organisation and requiring immunoglobulin replacement therapy due to hypogammaglobulinemia or agammaglobulinemia. The exact type
- •of PID should be recorded.
- •Previously treated with commercial Octagam 5% every 21-28 days for at least 6 infusion intervals at a constant dose between 200-800 mg/kg body weight
- •Availability of the IgG trough levels of the two previous infusions before enrollment, and maintenance of at least 5.5 g/L in the trough levels of these two
- •Negative result on a pregnancy test (HCG-based assay in blood or urine) forwomen of child-bearing potential and use of a reliable method of contraception for
- •the duration of the study.
- •For adult patients: freely given written informed consent. For minor patients:
- •freely given written informed consent from both parents/legal guardians and
- •written informed assent from the child/adolescent = 8 years of age, according to
- •his/her age and capacity of understanding.
- •Willingness to comply with all aspects of the protocol, including blood sampling,
- •for the duration of the study
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Acute infection requiring intravenous antibiotic treatment within two weeks before
- •Known history of adverse reactions to IgA in other products.
- •Exposure to blood or any blood product or derivative, other than a commercially
- •available Octagam 5%, within the past 3
- •Ongoing history of hypersensitivity or persistent reactions to blood or plasma
- •derived products, or any component of the investigational product, such as
- •Requirement of any routine pre-medication for IGIV infusion.
- •History of congenital impairment of pulmonary function.
- •Severe liver function impairment (ALAT 3x > normal value)
- •Severe renal function impairment (creatinine > 120 µmol/L), or predisposition for
- •acute renal failure (e.g. any degree of pre-existing renal insufficiency or routine
- •treatment with known nephritic drugs).
- •History of autoimmune haemolytic anemia.
- •History of diabetes mellitus.
- •Congestive heart failure NYHA III or IV.
- •None-controlled arterial hypertension (systolic blood pressure > 160 mm Hg
- •and/or diastolic blood pressure > 90 mm Hg).
- •History of DVT or thrombotic complications of IGIV therapy.
- •Known to be infected with HIV, HCV or HBV.
- •Presence of any clinically relevant disease or unstable condition beside those
- •concerning study indication at screening which in the opinion of the investigator
- •may interfere with the conduct of the study.
- •Treatment with steroids, immunosuppressive or immunomodulatory drugs.
- •Planned vaccination during the study period.
- •Treatment with any investigational agent within the prior 3 months.
- •Known or suspected to abuse alcohol, drugs, psychotropic agents or other
- •chemicals within the last 12 months.
- •Pregnant and/or nursing women.
研究者
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