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

Sponsor
Baxalta now part of Shire (Industry)
Overall Status
Completed
CT.gov ID
NCT00161993
Collaborator
(none)
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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
  • Drug: Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution
  • Drug: Gammagard S/D (Solvent/Detergent)
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Open-Label Study of Pharmacokinetics, Efficacy and Safety of Immune Globulin Intravenous (Human), 10% TVR Solution in Patients With Hypo- or Agammaglobulinemia
Actual Study Start Date :
Jun 13, 2002
Actual Primary Completion Date :
Sep 24, 2003
Actual Study Completion Date :
Sep 24, 2003

Outcome Measures

Primary Outcome Measures

  1. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

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.
Responsible Party:
Baxalta now part of Shire
ClinicalTrials.gov Identifier:
NCT00161993
Other Study ID Numbers:
  • 160001
First Posted:
Sep 13, 2005
Last Update Posted:
Aug 24, 2021
Last Verified:
Aug 1, 2021

Study Results

No Results Posted as of Aug 24, 2021