CLINICAL STUDY TO EVALUATE THE EFFICACY, PHARMACOKINETICS AND SAFETY OF IMMUNOGLOBULIN INTRAVENOUS (HUMAN) 10% (NEWGAM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES

OCTAPHARMA AG0 sites50 target enrollmentOctober 27, 2009

Overview

No summary available.

Registry

who.int

Start Date

October 27, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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.

•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.