Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia)
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the pharmacokinetics, efficacy and safety of Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution in subjects with primary immunodeficiency (PID) manifesting as hypo- or agammaglobulinemia. Subjects are treated every 21 days and receive a total of 12 infusions: for the first 3 infusions subjects receive GAMMAGARD S/D to ensure a steady-state and to acquire data with a licensed product; for the remaining 9 infusions subjects receive IGIV, 10% TVR Solution.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Outcome Measures
Primary Outcome Measures
- Pharmacokinetics: Trough levels of total immunoglobulin G (IgG) after treatment with Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution (IGIV, 10% TVR Solution) [21 days after each infusion (i.e., before the next infusion) of the study drug and at the last visit]
Eligibility Criteria
Criteria
Inclusion Criteria:
Subjects will be eligible for study entry if they:
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are at least 18 years old
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have a form of primary immunodeficiency (PID) as described by Rosen et al, 1999 16 manifesting as agammaglobulinemia (X-linked) or hypogamma-globulinemia (common variable immunodeficiency), requiring immunoglobulin replacement therapy
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have had regular treatment for at least three months with either intravenous immunoglobulin preparations or immunoglobulin preparations for intramuscular use given subcutaneously
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have serum IgG levels greater than or equal to 5 g/L as determined by the local laboratory at screening
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if female of childbearing potential, agree to employ adequate birth control measures during the study
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have given written informed consent
Exclusion Criteria:
Subjects will not be eligible for study entry if they:
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had severe adverse reactions to treatment with immunoglobulin preparations during the last three treatments before inclusion into the study
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suffer from documented selective IgA deficiency with antibodies against IgA
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have an acute infection that requires intravenous antibiotic treatment (Last treatment day should be seven days before study entry.)
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are known to be infected with HIV, HCV, or HBV
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are at high risk of contracting blood-borne viral infections through parenteral drug abuse or life style
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suffer from congestive heart failure and receive on-demand treatment with furosemide
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show renal dysfunction defined as serum creatinine greater than or equal to 1.5 mg/dL at baseline visit
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received another investigational drug in the three weeks preceding study entry
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in case of females, are pregnant or nursing mothers
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Tampere University Hospital | Tampere | Finland | 33 521 | |
2 | Turku University Central Hospital | Turku | Finland | 205 20 | |
3 | SU/Sahlgrenska | Gothenburg | Sweden | 41345 | |
4 | University Hospital Lund | Lund | Sweden | 221 85 | |
5 | University Hospital MAS | Malmö | Sweden | 205 02 | |
6 | Sundsvall Hospital | Sundsvall | Sweden | 851 86 |
Sponsors and Collaborators
- Baxalta now part of Shire
Investigators
- Study Director: Study Director, Takeda
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 160001