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OpenTrials
Completed

NCT Number: NCT01985373

Pharmacokinetics and Safety of IVIG 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.

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Key information

Conditions

Primary Immunodeficiency Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous immunoglobulin infusion

Drug

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

Primary outcomes

  1. IgG trough levels

    Time frame: before infusion

    Comparison IVIG 5% and 10%

  2. plasma concentration-time curve

    Time frame: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose

    Comparison IVIG 5% and 10%

  3. half-life

    Time frame: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose

    Comparison IVIG 5% and 10%

  4. area under the curve

    Time frame: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose

    Comparison IVIG 5% and 10%

  5. volume of distribution

    Time frame: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose

    Comparison IVIG 5% and 10%

  6. Cmax

    Time frame: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose

    Comparison IVIG 5% and 10%

  7. Tmax

    Time frame: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose

    Comparison IVIG 5% and 10%

  8. elimination rate constant(s)

    Time frame: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose

    Comparison IVIG 5% and 10%

Secondary outcomes

  1. Adverse Events

    Time frame: from first till 3 weeks after last infusion (11-19 weeks dependent on infusion frequency)

    number and type

Sponsors and collaborators

Lead sponsor

Prothya Biosolutions

Industry

Registry information

Official study title

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

Acronym: Nanogam

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 15, 2013
Registry last updated
Apr 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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