NCT00161993

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2002

Shorter than P25 for phase_2

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2002

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
Last Updated

August 24, 2021

Status Verified

August 1, 2021

Enrollment Period

1.3 years

First QC Date

September 8, 2005

Last Update Submit

August 22, 2021

Conditions

Primary Immunodeficiency Diseases (PID)AgammaglobulinemiaHypogammaglobulinemia

Keywords

Gammaglobulin

Outcome Measures

Primary Outcomes (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

Interventions

Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) SolutionDRUG
Gammagard S/D (Solvent/Detergent)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Subjects will not be eligible for study entry if they:
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Tampere University Hospital

Tampere, 33 521, Finland

Location

Turku University Central Hospital

Turku, 205 20, Finland

Location

SU/Sahlgrenska

Gothenburg, 41345, Sweden

Location

University Hospital Lund

Lund, 221 85, Sweden

Location

University Hospital MAS

Malmo, 205 02, Sweden

Location

Sundsvall Hospital

Sundsvall, 851 86, Sweden

Location

MeSH Terms

Conditions

Primary Immunodeficiency DiseasesAgammaglobulinemia

Interventions

gamma-GlobulinsSolutionsSolventsDetergents

Condition Hierarchy (Ancestors)

Genetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesImmunologic Deficiency SyndromesImmune System DiseasesBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic Diseases

Intervention Hierarchy (Ancestors)

ImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPharmaceutical PreparationsSpecialty Uses of ChemicalsChemical Actions and UsesSurface-Active AgentsHousehold ProductsTechnology, Industry, and Agriculture

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 13, 2005

Study Start

June 13, 2002

Primary Completion

September 24, 2003

Study Completion

September 24, 2003

Last Updated

August 24, 2021

Record last verified: 2021-08

Locations

FI(2)SE(4)