Efficacy and Safety of Vivaglobin® in Previously Untreated Patients With Primary Immunodeficiency - Full Text View

Sponsored by:	CSL Behring
Information provided by:	CSL Behring
ClinicalTrials.gov Identifier:	NCT00520494

Purpose

The objective of this study is to assess the efficacy and safety of Vivaglobin in previously untreated patients (PUPs) with PID over a 6-month observation period. The purpose is to investigate whether PUPs will respond to subcutaneous immunoglobulin (SCIG) treatment with adequate trough levels without first receiving immunoglobulins by the intravenous route by demonstrating that 100 mg IgG/kg bw administered on 5 consecutive days (i.e. resulting in a total dose of 500 mg IgG/kg bw) results in an IgG increase to ≥500 mg/dL on Day 12 after initiation of SCIG therapy.

Condition	Intervention	Phase
Common Variable Immunodeficiency Agammaglobulinemia	Drug: Human normal immunoglobulin for subcutaneous use	Phase IV

Genetics Home Reference related topics: aceruloplasminemia X-linked agammaglobulinemia

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multicenter Study on the Efficacy and Safety of Vivaglobin® in Previously Untreated Patients (PUPs) With Primary Immunodeficiency (PID)

Further study details as provided by CSL Behring:

Primary Outcome Measures:

The primary efficacy endpoint consists of the proportion of patients achieving IgG levels ≥500 mg/dL on Day 12

Secondary Outcome Measures:

Overall rate of infections
Serum concentrations of specific IgGs
Total serum IgG trough levels
Quality of life as measured by an adapted SF-36 (age ≥14 years) or CHQ-PF50 (age ≤13 years)
Use of antibiotics for infection prophylaxis and treatment
Overall rate, severity and relatedness of any adverse event (AE) per infusion and patient
Changes in routine laboratory parameters (blood chemistry, hematology, urinalysis) as compared to baseline assessments

Estimated Enrollment:	28
Study Start Date:	March 2007
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	1 Year to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria:

Written informed consent, age-adapted
Male or female aged 1 to 70 years
Diagnosis of primary humoral immunodeficiency
No prior immunoglobulin substitution therapy
IgG level of <500 mg/dL at screening
Women of childbearing potential must use medically approved contraception and must have a negative urine pregnancy test at screening

Key Exclusion Criteria:

Evidence of serious infection between screening and first treatment
Bleeding disorders that require medical treatments
Any medical disorder causing secondary immune disorders, autoimmune neutropenia, or a clinically significant defect in cell mediated immunity
Any condition 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: NCT00520494

Locations

Germany

Leipzig, Germany, 04129

Sponsors and Collaborators

CSL Behring

Investigators

Principal Investigator:

Michael Borte, MD

Klinik für Kinder-und Jugendmedizin am Städtischen Klinikum St. Georg

More Information

Study ID Numbers:	ZLB06_005CR
Study First Received:	August 23, 2007
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00520494
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by CSL Behring:

Previously Untreated Patient (PUP)
Primary Immunodeficiency (PID)
CVID
XLA
Subcutaneous immunoglobulin (SCIG)

IgG trough level
Quality of life
Common variable immunodeficiency (CVID)
X-linked agammaglobulinemia (XLA)

Study placed in the following topic categories:

Agammaglobulinemia
Common variable immunodeficiency
Blood Protein Disorders
Hematologic Diseases
Quality of Life
Bruton type agammaglobulinemia
Immunologic Deficiency Syndromes

Lymphatic Diseases
Antibodies
X-linked agammaglobulinemia
Lymphoproliferative Disorders
Common Variable Immunodeficiency
Immunoglobulins

Additional relevant MeSH terms:

Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009