Back to resultsPharmacokinetics and Safety of IVIG Nanogam 100 mg/ml (Nanogam)
Primary Purpose
Primary Immunodeficiency
Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Intravenous immunoglobulin infusion
Sponsored by
About this trial
This is an interventional treatment trial for Primary Immunodeficiency focused on measuring intravenous immunoglobulin, pharmacokinetics, 10% IVIG
Eligibility 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
Sites / Locations
- Jeroen Bosch Ziekenhuis
- UMCG
- LUMC
- UMC St. Radboud
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intravenous immunoglobulin infusion
Arm Description
One intravenous infusion with Nanogam 50 mg/ml and 4 with Nanogam 100 mg/ml (0.2-0.8 g/kg)
Outcomes
Primary Outcome Measures
IgG trough levels
Comparison IVIG 5% and 10%
plasma concentration-time curve
Comparison IVIG 5% and 10%
half-life
Comparison IVIG 5% and 10%
area under the curve
Comparison IVIG 5% and 10%
volume of distribution
Comparison IVIG 5% and 10%
Cmax
Comparison IVIG 5% and 10%
Tmax
Comparison IVIG 5% and 10%
elimination rate constant(s)
Comparison IVIG 5% and 10%
Secondary Outcome Measures
Adverse Events
number and type
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01985373
Brief Title
Pharmacokinetics and Safety of IVIG Nanogam 100 mg/ml
Acronym
Nanogam
Official Title
Pharmacokinetics and Safety of the Intravenous Human Immunoglobulin Product Nanogam 100 mg/ml
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prothya Biosolutions
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Immunodeficiency
Keywords
intravenous immunoglobulin, pharmacokinetics, 10% IVIG
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intravenous immunoglobulin infusion
Arm Type
Experimental
Arm Description
One intravenous infusion with Nanogam 50 mg/ml and 4 with Nanogam 100 mg/ml (0.2-0.8 g/kg)
Intervention Type
Drug
Intervention Name(s)
Intravenous immunoglobulin infusion
Other Intervention Name(s)
Nanogam
Intervention Description
Blood samples are drawn before infusion with Nanogam 50 and Nanogam 100 mg/ml and IgG levels are determined to study PK
Primary Outcome Measure Information:
Title
IgG trough levels
Description
Comparison IVIG 5% and 10%
Time Frame
before infusion
Title
plasma concentration-time curve
Description
Comparison IVIG 5% and 10%
Time Frame
predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
Title
half-life
Description
Comparison IVIG 5% and 10%
Time Frame
predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
Title
area under the curve
Description
Comparison IVIG 5% and 10%
Time Frame
predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
Title
volume of distribution
Description
Comparison IVIG 5% and 10%
Time Frame
predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
Title
Cmax
Description
Comparison IVIG 5% and 10%
Time Frame
predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
Title
Tmax
Description
Comparison IVIG 5% and 10%
Time Frame
predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
Title
elimination rate constant(s)
Description
Comparison IVIG 5% and 10%
Time Frame
predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
Secondary Outcome Measure Information:
Title
Adverse Events
Description
number and type
Time Frame
from first till 3 weeks after last infusion (11-19 weeks dependent on infusion frequency)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
F P Kroon, PhD, MD
Organizational Affiliation
LUMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jeroen Bosch Ziekenhuis
City
Den Bosch
Country
Netherlands
Facility Name
UMCG
City
Groningen
Country
Netherlands
Facility Name
LUMC
City
Leiden
Country
Netherlands
Facility Name
UMC St. Radboud
City
Nijmegen
Country
Netherlands
12. IPD Sharing Statement
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Pharmacokinetics and Safety of IVIG Nanogam 100 mg/ml
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