Study of Subcutaneous Immunoglobulin Human in Patients With PID Requiring IgG Replacement Therapy - Full Text View

Purpose

The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgG with Proline (IgPro) in subjects with PID. The study should evaluate whether the rate of clinically documented serious bacterial infections (SBIs) per subject per year is less than 1.The primary objective of the pharmacokinetic (PK) substudy is to show that the chosen SC dose regimen is associated with steady-state AUCs not inferior to those obtained with the previous IV dose regimen. Secondary objectives of the PK substudy are to determine the PK parameters AUC, Cmax and Tmax of total IgG, and the serum concentration of IgG subclasses, specific IgGs and L-proline.

Condition	Intervention	Phase
Primary Immunodeficiency (PID)	Drug: IgG with Proline (IgPro)	Phase III

ChemIDplus related topics:

Globulin, Immune Immunoglobulins Proline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Phase III Open-Label, Prospective, Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human), (IgG With Proline - IgPro) in Subjects With Primary Immunodeficiency (PID)

Further study details as provided by CSL Behring:

Primary Outcome Measures:

Rate of clinically documented SBIs defined as: Bacterial pneumonia [ Time Frame: Checked every day during study ] [ Designated as safety issue: Yes ]
Bacteremia and septicemia [ Time Frame: Checked every day during study ] [ Designated as safety issue: Yes ]
Osteomyelitis / septic arthritis [ Time Frame: Checked every day during study ] [ Designated as safety issue: Yes ]
Bacterial meningitis [ Time Frame: Checked every day during study ] [ Designated as safety issue: Yes ]
Visceral abscess [ Time Frame: Checked every day during study ] [ Designated as safety issue: Yes ]
Show non-inferiority in steady-state AUC of IgG levels of weekly infusions of IgG with Proline (IgPro)compared to the previous 3 or 4 weekly IVIG treatment [ Time Frame: Obtained after at least 12 weeks of stable SC dosing with IgPro ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of infection episodes (serious and non-serious) [ Time Frame: Will be recorded as they occur during study ] [ Designated as safety issue: Yes ]
Number of days of hospitalization due to infections [ Time Frame: Will be recorded as they occur during study ] [ Designated as safety issue: Yes ]
Use of antibiotics for infection prophylaxis and treatment [ Time Frame: Will be recorded as they occur during study ] [ Designated as safety issue: Yes ]
Total serum IgG trough levels [ Time Frame: Every 4 weeks during study ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	November 2006
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Liquid formulation; weekly dosage calculated based on previous IVIG treatment

Eligibility

Ages Eligible for Study:	2 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female aged 2 to 75 years
Subjects with primary humoral immunodeficiency, namely with a diagnosis of: CVID (Common Variable Immunodeficiency) as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies) or XLA (X-linked Agammaglobulinemia)
Written informed consent

Exclusion Criteria:

Newly diagnosed PID
Evidence of an active serious infection at the time of screening (i.e., but not limited to: bacteremia/septicemia, pneumonia, fungal osteomyelitis)
Malignancies of lymphoid cells such as lymphocytic leukemia, Non-Hodgkin's lymphoma and immunodeficiency with thymoma
Known hyperprolinemia
Hypoalbuminemia, protein-losing enteropathies, and any proteinuria
Allergic reactions to immunoglobulins or other blood products
Known antibodies to IgA
The subject is receiving steroids (oral and parenteral, daily ≥ 0.15 mg of prednisone equivalent/kg/day) or other systemic immunosuppressants
Female who is pregnant, breast feeding or planning a pregnancy during the course of the study
Participation in a study with an investigational product other than IVIG within 1 month prior to enrollment
A positive result at screening on any of the following viral markers: HIV, HCV and HBV
ASAT or ALAT concentration > 2.5 times the UNL· Creatinine concentration > 1.5 times the UNL
Any condition that is likely to interfere with evaluation of the study drug or satisfactory conduct of the trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419341

Locations


United States, Minnesota

	Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

CSL Behring

More Information

Responsible Party:	CSL Behring ( Christian Peters / MD, PhD )
Study ID Numbers:	ZLB04_009CR
First Received:	December 22, 2006
Last Updated:	February 6, 2008
ClinicalTrials.gov Identifier:	NCT00419341
Health Authority:	United States: Food and Drug Administration

Keywords provided by CSL Behring:

Immune globulin subcutaneous

SCIG

Primary immunodeficiency

PID

Study placed in the following topic categories:

Immunologic Deficiency Syndromes

Immunoglobulins

Additional relevant MeSH terms:

Immunologic Factors

Immune System Diseases

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	CSL Behring
Information provided by:	CSL Behring
ClinicalTrials.gov Identifier:	NCT00419341