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

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ClinicalTrials.gov Identifier: NCT01985373
Recruitment Status : Completed
First Posted : November 15, 2013
Last Update Posted : April 6, 2015
Sponsor:
Information provided by (Responsible Party):
Sanquin Plasma Products BV

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

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Study Type : Interventional  (Clinical Trial)
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 : December 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015


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 Name: Nanogam




Primary Outcome Measures :
  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 Outcome Measures :
  1. Adverse Events [ Time Frame: from first till 3 weeks after last infusion (11-19 weeks dependent on infusion frequency) ]
    number and type



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01985373


Locations
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Netherlands
Jeroen Bosch Ziekenhuis
Den Bosch, Netherlands
UMCG
Groningen, Netherlands
LUMC
Leiden, Netherlands
UMC St. Radboud
Nijmegen, Netherlands
Sponsors and Collaborators
Sanquin Plasma Products BV
Investigators
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Principal Investigator: F P Kroon, PhD, MD LUMC
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Responsible Party: Sanquin Plasma Products BV
ClinicalTrials.gov Identifier: NCT01985373    
Other Study ID Numbers: MD2012.02
2012-005727-32 ( EudraCT Number )
First Posted: November 15, 2013    Key Record Dates
Last Update Posted: April 6, 2015
Last Verified: April 2015
Keywords provided by Sanquin Plasma Products BV:
intravenous immunoglobulin
pharmacokinetics
10% IVIG
Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs