Pharmacokinetics and safety of the intravenous human immunoglobulin product Nanogam 100 mg/ml

Phase 3

Completed

• Conditions: congenital antibody immune disorder; primary hypogammaglobulinemia; 10021429; 10021460

• Registration Number: NL-OMON38799
• Lead Sponsor: Sanquin Bloedvoorziening

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- Primary a- or hypogammaglobulinemia, particularly patients with XLA or CVID
- Stabilised on treatment with Nanogam (50 mg/ml) with 2-4 weeks intervals in an hospital or at home and willing to be treated with 1 infusion of Nanogam 50 mg/ml and 4 infusions of Nanogam 100 mg/ml at the hospital
- A stable clinical situation (no activity of any other disease; a stable immunoglobulin dose and frequency)
- Age 18 years or older
- The patient has signed the consent form

Exclusion Criteria

- Known with allergic reactions against human plasma or plasma products
- Having an ongoing progressive disease, including HIV infection
- Pregnancy or lactation
- Known with insufficiency of coronary or cerebral circulation
- Having renal insufficiency (plasma creatinin > 115µmol/L)
- Having IgA deficiency and anti-IgA antibodies have been detected

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are the plasma concentration-time curve, half-life,<br /><br>area under the curve (AUC), volume of distribution (Vd), Cmax, Tmax, and<br /><br>elimination rate constant(s) are calculated. PK parameters obtained with the<br /><br>Nanogam 50 mg/ml and Nanogam 100 mg/ml will be compared. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety will be monitored by measuring vital signs and recording all adverse<br /><br>events during and after the infusions (number and type).</p><br>