ISRCTN05425999
Completed
N/A
Clinical study to evaluate the efficacy, pharmacokinetics and safety of immunoglobulin intravenous (human) 10% (NewGam) in patients with primary immunodeficiency diseases
Octapharma AG (Switzerland)0 sites50 target enrollmentNovember 11, 2009
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Primary immunodeficiency diseases (PID)
- Sponsor
- Octapharma AG (Switzerland)
- Enrollment
- 50
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Aged greater than or equal to 2 years and less than or equal to 75 years, either sex
- •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 manoeuvre) 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 common variable immunodeficiency (CVID) or X\-linked agammaglobulinaemia (XLA)
- •4\. Previously treated with a commercial immune globulin intravenous (human) every 21 \- 28 days for at least 6 infusion intervals at a constant dose between 200 and 800 mg/kg body weight
- •5\. Availability of the immunoglobulin G (IgG) trough levels of the two previous infusions before enrolment, and maintenance of at least 5\.5 g/l in the trough levels of these two infusions
- •6\. Negative result on a pregnancy test (human chorionic gonadotrophin \[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
Exclusion Criteria
- •1\. Acute infection requiring intravenous antibiotic treatment within 2 weeks prior to and during the screening period
- •2\. Known history of adverse reactions to immunoglobulin A (IgA) in other products
- •3\. Exposure to blood or any blood product or derivative, other than commercially available intravenous immunoglobulin (IVIG), within the past 3 months prior to enrolment
- •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 pre\-medication for IVIG infusion
- •6\. History of congenital impairment of pulmonary function
- •7\. Severe liver function impairment (alanine aminotransferase \[ALAT] 3 x upper limit of normal)
- •8\. Presence of renal function impairment (creatinine greater than 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)
- •9\. History of autoimmune haemolytic anaemia
- •10\. History of diabetes mellitus
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, Not Recruiting
Phase 3
Clinical study to assess how well wilate works in the regular treatment of young children with severe von Willebrand diseaseISRCTN11217735Octapharma (Austria)12
Completed
Phase 2
A Clinical study on cervical spondylosis using thengaai thuruval ottradam (external therapy)Health Condition 1: M478- Other spondylosisCTRI/2021/02/031542Government Siddha medical college and hospital40
Recruiting
N/A
Effect of trutyadi churna in amavata with special reference to rheumatoid arthritis.Health Condition 1: M049- Autoinflammatory syndrome, unspecifiedCTRI/2021/08/035463DR VISHNUPRIYA SEETHARAM
Not Yet Recruiting
Phase 3
Ayurvedic medicine-siddartakadi yoga in depressioHealth Condition 1: F320- Major depressive disorder, singleepisode, mildCTRI/2024/04/065341I
Active, Not Recruiting
Phase 1
Clinical study to find out how well wilate works in little children with severe von Willebrand diseaseEUCTR2020-004344-28-DEOctapharma Pharmazeutika Produktionsges.m.b.H.12