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

August 22, 2021 updated by: Baxalta now part of Shire

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland, 33 521
        • Tampere University Hospital
      • Turku, Finland, 205 20
        • Turku University Central Hospital
  • Sweden
      • Gothenburg, Sweden, 41345
        • SU/Sahlgrenska
      • Lund, Sweden, 221 85
        • University Hospital Lund
      • Malmö, Sweden, 205 02
        • University Hospital MAS
      • Sundsvall, Sweden, 851 86
        • Sundsvall Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxalta now part of Shire

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2002

Primary Completion (Actual)

September 24, 2003

Study Completion (Actual)

September 24, 2003

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 13, 2005

Study Record Updates

Last Update Posted (Actual)

August 24, 2021

Last Update Submitted That Met QC Criteria

August 22, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 160001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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