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

Primary Immunodeficiency Diseases (PID) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00161993
• Other study ID #: 160001
• Status: Completed
• Phase: Phase 2
• Start date: June 13, 2002
• Est. completion date: September 24, 2003

Study information

• Verified date: August 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 24, 2003
• Est. primary completion date: September 24, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Agammaglobulinemia
• Hypogammaglobulinemia
• Immunologic Deficiency Syndromes
• Primary Immunodeficiency Diseases (PID)

Intervention

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

• Gammagard S/D (Solvent/Detergent)

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere
Finland	Turku University Central Hospital	Turku
Sweden	SU/Sahlgrenska	Gothenburg
Sweden	University Hospital Lund	Lund
Sweden	University Hospital MAS	Malmö
Sweden	Sundsvall Hospital	Sundsvall

Sponsors (1)

Lead Sponsor	Collaborator
Baxalta now part of Shire

Countries where clinical trial is conducted

Finland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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