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Clinical Trials/NCT00161993
NCT00161993CompletedPhase 2

Prospective Open-Label Study of Pharmacokinetics, Efficacy and Safety of Immune Globulin Intravenous (Human), 10% TVR Solution in Patients With Hypo- or Agammaglobulinemia

Baxalta now part of Shire6 sites in 2 countries24 target enrollmentStarted: June 13, 2002Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
24
Locations
6
Primary Endpoint
Pharmacokinetics: Trough levels of total immunoglobulin G (IgG) after treatment with Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution (IGIV, 10% TVR Solution)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

Pharmacokinetics: Trough levels of total immunoglobulin G (IgG) after treatment with Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution (IGIV, 10% TVR Solution)

Time Frame: 21 days after each infusion (i.e., before the next infusion) of the study drug and at the last visit

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Baxalta now part of Shire
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (6)

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