Pharmacokinetics and Safety of IVIG Nanogam 100 mg/ml

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Immunodeficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intravenous immunoglobulin infusion

One intravenous infusion with Nanogam 50 mg/ml and 4 with Nanogam 100 mg/ml (0.2-0.8 g/kg)

Group Type EXPERIMENTAL

Intravenous immunoglobulin infusion

Intervention Type DRUG

Blood samples are drawn before infusion with Nanogam 50 and Nanogam 100 mg/ml and IgG levels are determined to study PK

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Nanogam

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No