Pharmacokinetics and Safety of IVIG Nanogam 100 mg/ml

Sponsor

Prothya Biosolutions (Industry)

Overall Status

Completed

CT.gov ID

NCT01985373

Collaborator

(none)

Enrollment

Locations

Arm

14.9

Duration (Months)

5.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Immunodeficiency	Drug: Intravenous immunoglobulin infusion	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse Events [from first till 3 weeks after last infusion (11-19 weeks dependent on infusion frequency)]
number and type

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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