Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia)

Phase 2

Completed

• Conditions: Agammaglobulinemia; Primary Immunodeficiency Diseases (PID); Hypogammaglobulinemia

• Registration Number: NCT00161993
• Lead Sponsor: Baxalta now part of Shire

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06-13
• Primary Completion: 2003-09-24
• Study Completion: 2003-09-24
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-13
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-22
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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 Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

Turku University Central Hospital; 🇫🇮 Turku, Finland

University Hospital MAS; 🇸🇪 Malmö, Sweden

Sundsvall Hospital; 🇸🇪 Sundsvall, Sweden

University Hospital Lund; 🇸🇪 Lund, Sweden

Tampere University Hospital; 🇫🇮 Tampere, Finland

SU/Sahlgrenska; 🇸🇪 Gothenburg, Sweden