EUCTR2009-011434-10-Outside-EU/EEA进行中（未招募）不适用
CLINICAL STUDY TO EVALUATE THE EFFICACY, PHARMACOKINETICS AND SAFETY OF IMMUNOGLOBULIN INTRAVENOUS (HUMAN) 10% (NEWGAM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 51
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
- 性别
- All
入选标准
- •Patients who meet the following criteria can be included:
- •1. Age of = 2 years and = 75 years.
- •2. 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 maneuver) should not exceed 3% of the total blood volume during a period of 4 weeks and should not exceed 1% at any single time (the total volume of blood is estimated at 80 mL/kg body weight).
- •3. Confirmed diagnosis of CVID or XLA.
- •4. Previously treated with a commercial immune globulin intravenous (human)
- •a) every 21–28 days for at least 6 infusion intervals (± 3 days for the last three infusions and ± 7 days for the three infusions before the last three infusions)
- •b) at a constant dose between 200 and 800 mg/kg body weight (± 20% of the mean dose for the last 6 infusions).
- •5. Availability of the IgG trough levels of the 2 previous infusions before enrollment, and maintenance of at least 5.5 g/L in the trough levels of these 2 infusions.
- •6. Negative result on a pregnancy test (HCG-based assay in urine) for women of childbearing potential and use of a reliable method of contraception for the duration of the study.
- •7. For adult patients: freely given written informed consent. For minor patients: freely given written informed consent from parents/legal guardians and written informed assent from the child/adolescent in accordance with the applicable approvals.
- •8. 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: 24
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1. Acute infection requiring intravenous antibiotic treatment within 2 weeks prior to and during the screening period.
- •2. Known history of adverse reactions to IgA in other products.
- •3. Exposure to blood or any blood product or derivative, other than commercially available IVIG, within the past 3 months prior to enrollment.
- •4. Ongoing history of hypersensitivity or persistent reactions to blood or plasma derived products, or any component of the investigational product.
- •5. Requirement of any routine premedication for IVIG infusion.
- •6. History of congenital impairment of pulmonary function.
- •7. Severe liver function impairment (ALAT 3x > upper limit of normal).
- •8. Presence of renal function impairment (creatinine > 120 micromol/L), or predisposition for acute renal failure (e.g. any degree of pre-existing renal insufficiency or routine treatment with known nephritic drugs).
- •9. History of autoimmune hemolytic anemia.
- •10. History of diabetes mellitus.
- •11. Congestive heart failure NYHA class III or IV.
- •12. Non-controlled arterial hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 90 mmHg).
- •13. History of deep vein thrombosis or thrombotic complications of IVIG therapy.
- •14. A positive result at screening on any of the following viral markers: HIV, HCV, HBV.
- •15. Presence of any clinically relevant disease or unstable condition at screening, other than PID, which in the opinion of the investigator could interfere with the conduct of the study.
- •16. Treatment with steroids (oral or parenteral, long-term, i.e. 30 days or more, not intermittent or burst, daily, = 0.15 mg of prednisone or equivalent/kg/day), immunosuppressive or immunomodulatory drugs.
- •17. Planned vaccination during the study period.
- •18. Treatment with any investigational agent within 3 months prior to enrollment.
- •19. Known or suspected to abuse alcohol, drugs, psychotropic agents or other chemicals within the past 12 months prior to enrollment.
- •20. Pregnant or nursing women.
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