Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients

• Status: Completed
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to determine if the safety and tolerability of Immune Globulin Intravenous (Human), 10% caprylate/chromatography (IGIV-C)purified is similar when infused at two different infusion rates. The primary objective is to compare the incidence and severity of all infusion related adverse events when IGIV-C, 10% is administered at a rate of 0.14 mL/kg/min compared to a rate of 0.08 mL/kg/min after a single daily infusion.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grifols Therapeutics Inc.; Grifols Therapeutics LLC
• Treatments: Antibodies; gamma-Globulins; Immunoglobulin G; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

Criteria

Inclusion Criteria:

• Confirmed diagnosis of primary immune deficiency and medical records available for retrospective review for at least 3 months prior to entry into the trial

• Signed an informed consent written informed consent prior to initiation of any study related procedures

• Receiving regular infusions of IGIV at a fixed interval and dosage (in the range of 200-600 mg/kg given every 3-4 weeks) for at least three months prior to entry into the trial. Patients who are currently receiving less than 400 mg/kg are eligible for this trial and will be at the time of study enrollment be treated at 400 mg/kg

Exclusion Criteria:

• History or suspicion of significant allergic reaction to intravenous immune globulin, and/or blood products

• Documented history of selective IgA deficiency (serum level <5.0 mg/dL) and known antibodies to IgA

• Isolated IgG subclass deficiency with a normal total serum IgG level

• Other conditions which may interfere with the trial, include the patients demeanor or mental ability to follow instruction.

• Pretreatment with anti-pyretics or anti-histamines

• Congestive heart failure (New York Heart Association stage greater than Class II)

• Renal insufficiency (creatinine >2.5 mg/dL)

• Conditions whose symptoms and effects could alter protein catabolism and/or IgG utilization (e.g. protein-losing enteropathies, nephrotic syndrome)

• Pretreatment routinely required to control/ameliorate IGIV infusion-related adverse events (AEs)

• Any patient who requires IGIV dosing more frequently than every 3 weeks to maintain adequate trough levels

• Women of child bearing potential who do not practice adequate contraception (i.e. chemical or mechanical methods) and pregnant or lactating females