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Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)

Information source: CSL Behring
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Agammaglobulinemia; IgG Deficiency; Common Variable Immunodeficiency

Intervention: Immunoglobulins Intravenous (Human) (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: CSL Behring

Summary

The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety, the number of infusions temporally associated with AEs, the rate, severity and relationship of all AEs and the vital sign changes during each infusion will be evaluated.

Clinical Details

Official title: A Multicenter Extension Study on the Safety and Efficacy of IgPro10 in Patients With Primary Immunodeficiency (PID)

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

Primary outcome:

Safety endpoints: The proportion of infusions temporally (during infusion and within 48 hours after the end of infusion) associated with one or more AEs

Influence of infusion rate on adverse events

Rate, severity and relationship of all AEs

Vital sign changes during each infusion

Secondary outcome:

Efficacy endpoints: Rate of acute serious bacterial infections;

Number of days out of work / school / kindergarten / day care due to underlying PID

Number of days of hospitalization

Rate of any infections

Trough levels of total IgG serum concentrations

Eligibility

Minimum age: 4 Years. Maximum age: 71 Years. Gender(s): Both.

Criteria:

Key Inclusion Criteria:

- Patients with CVID (Common Variable Immunodeficiency) or XLA (X-linked

agammaglobulinemia) who have participated in the Phase III clinical study with intravenous IgPro10 (study number ZLB03_002CR) at 3- or 4- weekly intervals for 12 months

- Written informed consent

Key Exclusion Criteria:

- Diagnosis of epilepsia

- Insulin dependent diabetes

- Administration of steroids (daily ≥ 0. 15 mg prednisone equivalent/kg/day) or other

immunosuppressive drugs

- History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart

failure, severe hypertension

Locations and Contacts

Indianapolis, Indiana 46202, United States
Additional Information

Starting date: November 2005
Ending date: April 2008
Last updated: January 4, 2008

Page last updated: March 21, 2008

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