Pharmacokinetics and Safety of IVIG Nanogam 100 mg/ml (Nanogam)

Pharmacokinetics and Safety of the Intravenous Human Immunoglobulin Product Nanogam 100 mg/ml

Intravenous immunoglobulin (IVIG) is used for treatment of a heterogeneous group of immune related disorders both as immune-replacement and immune-modulating therapy. Sanquin developed a 100 mg/ml IVIg product (Nanogam 100 mg/ml). Patient will receive one infusion with Nanogam 50 mg/ml as they used to (same dose) and subsequently 4 infusions with Nanogam 100 mg/ml (same dose). Aim is to show bioequivalency between the 50 mg/ml and the 100 mg/ml product of Sanquin.

Study Overview

• Status: Completed
• Conditions: Primary Immunodeficiency
• Intervention / Treatment: Drug: Intravenous immunoglobulin infusion

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 3

Contacts and Locations

Study Locations

• Netherlands
  • Den Bosch, Netherlands
    • Jeroen Bosch Ziekenhuis
  • Groningen, Netherlands
    • UMCG
  • Leiden, Netherlands
    • LUMC
  • Nijmegen, Netherlands
    • UMC St. Radboud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intravenous immunoglobulin infusion; One intravenous infusion with Nanogam 50 mg/ml and 4 with Nanogam 100 mg/ml (0.2-0.8 g/kg)	Drug: Intravenous immunoglobulin infusion; Blood samples are drawn before infusion with Nanogam 50 and Nanogam 100 mg/ml and IgG levels are determined to study PK; Other Names: Nanogam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IgG trough levels	Comparison IVIG 5% and 10%	before infusion
plasma concentration-time curve	Comparison IVIG 5% and 10%	predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
half-life	Comparison IVIG 5% and 10%	predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
area under the curve	Comparison IVIG 5% and 10%	predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
volume of distribution	Comparison IVIG 5% and 10%	predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
Cmax	Comparison IVIG 5% and 10%	predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
Tmax	Comparison IVIG 5% and 10%	predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
elimination rate constant(s)	Comparison IVIG 5% and 10%	predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	number and type	from first till 3 weeks after last infusion (11-19 weeks dependent on infusion frequency)

Collaborators and Investigators

• Sponsor: Prothya Biosolutions
• Investigators: Principal Investigator: F P Kroon, PhD, MD, LUMC

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: October 31, 2013
• First Submitted That Met QC Criteria: November 8, 2013
• First Posted (Estimate): November 15, 2013

Study Record Updates

• Last Update Posted (Estimate): April 6, 2015
• Last Update Submitted That Met QC Criteria: April 3, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: pharmacokinetics; intravenous immunoglobulin; 10% IVIG
• Additional Relevant MeSH Terms: Immunologic Deficiency Syndromes; Immune System Diseases; Genetic Diseases, Inborn; Primary Immunodeficiency Diseases; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous; gamma-Globulins; Rho(D) Immune Globulin
• Other Study ID Numbers: MD2012.02; 2012-005727-32 (EudraCT Number)