Status:
COMPLETED
Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia)
Lead Sponsor:
Baxalta now part of Shire
Conditions:
Primary Immunodeficiency Diseases (PID)
Agammaglobulinemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 immunodef...
Eligibility Criteria
Inclusion
- Subjects will be eligible for study entry if they:
- are at least 18 years old
- 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
- have had regular treatment for at least three months with either intravenous immunoglobulin preparations or immunoglobulin preparations for intramuscular use given subcutaneously
- have serum IgG levels greater than or equal to 5 g/L as determined by the local laboratory at screening
- if female of childbearing potential, agree to employ adequate birth control measures during the study
- have given written informed consent
Exclusion
- Subjects will not be eligible for study entry if they:
- had severe adverse reactions to treatment with immunoglobulin preparations during the last three treatments before inclusion into the study
- suffer from documented selective IgA deficiency with antibodies against IgA
- have an acute infection that requires intravenous antibiotic treatment (Last treatment day should be seven days before study entry.)
- are known to be infected with HIV, HCV, or HBV
- are at high risk of contracting blood-borne viral infections through parenteral drug abuse or life style
- suffer from congestive heart failure and receive on-demand treatment with furosemide
- show renal dysfunction defined as serum creatinine greater than or equal to 1.5 mg/dL at baseline visit
- received another investigational drug in the three weeks preceding study entry
- in case of females, are pregnant or nursing mothers
Key Trial Info
Start Date :
June 13 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2003
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00161993
Start Date
June 13 2002
End Date
September 24 2003
Last Update
August 24 2021
Active Locations (6)
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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