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

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Baxalta

Status and phase

Completed
Phase 2

Conditions

Hypogammaglobulinemia
Primary Immunodeficiency Diseases (PID)
Agammaglobulinemia

Treatments

Drug: Gammagard S/D (Solvent/Detergent)
Drug: Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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