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

NCT ID: NCT00161993

Last Updated: 2021-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-13
• Study Completion Date: 2003-09-24

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.

Conditions

Primary Immunodeficiency Diseases (PID); Agammaglobulinemia; Hypogammaglobulinemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution

Intervention Type: DRUG

Gammagard S/D (Solvent/Detergent)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxalta now part of Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Tampere University Hospital

Tampere, , Finland

Turku University Central Hospital

Turku, , Finland

SU/Sahlgrenska

Gothenburg, , Sweden

University Hospital Lund

Lund, , Sweden

University Hospital MAS

Malmo, , Sweden

Sundsvall Hospital

Sundsvall, , Sweden

Countries

Finland; Sweden

Other Identifiers

160001

Identifier Type: -

Identifier Source: org_study_id