A Multicenter Study of Efficacy, Safety, Tolerability, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency

CSL Behring1 site in 1 country25 target enrollmentSeptember 2010

ConditionsPrimary Immune Deficiency

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Primary Immune Deficiency
Sponsor: CSL Behring
Enrollment: 25
Locations: 1
Primary Endpoint: IgG Trough Level
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics of a subcutaneous immune globulin (SCIG; IgPro20) in subjects with primary immunodeficiency (PID). In addition, the study will assess the health-related quality of life and pharmacoeconomic aspects related to treatment with IgPro20.

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

November 2011

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

CSL Behring

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis of PID with hypo- or agammaglobulinemia requiring IgG replacement therapy
•Intravenous IgG (IVIG) therapy at regular 3- or 4-week intervals at a stable dose for at least 3 doses prior to signing of informed consent
•Written informed consent

Exclusion Criteria

•Newly diagnosed PID, i.e., subjects who have not previously received immunoglobulin replacement therapy
•Ongoing serious bacterial infections (SBIs: pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time of screening
•Ongoing or history of concomitant malignancies of lymphoid cells such as lymphocytic leukemia, non-Hodgkin's lymphoma, and immunodeficiency with thymoma
•Allergic or other severe reactions to immunoglobulins or other blood products recorded in the past 3 months or at the time of screening
•Pregnancy or nursing mother
•A positive result at screening on any of the following viral markers: human immunodeficiency virus-1 (HIV-1), HIV-2, hepatitis C virus, or hepatitis B virus
•Participation in a study with other investigational product during this study and within 3 months prior to screening
•Subjects who donated blood (200 mL within one month or 400 mL within 3 months prior to screening), or planning to donate blood during the study

Outcomes

Primary Outcomes

IgG Trough Level

Time Frame: During IVIG period (IV 1, IV 2, IV 3) and during SCIG period at weeks 16, 20, and 24

Geometric means of trough levels measured before 3 intravenous immunoglobulin (IVIG) infusions was compared with those of trough levels measured at steady-state for 3 subcutaneous immunoglobulin (SCIG) infusions (weeks 16, 20 and 24). The ratio of these geometric means was the primary outcome measure.

Secondary Outcomes

Number of Infection Episodes (Serious and Non-serious) by Study Period(Up to 36 weeks)
Rate of Infection Episodes (Serious and Non-serious) by Study Period, PPS Population(Up to 36 weeks)
Number of Days of Hospitalization Due to Infections by Study Period(Up to 36 weeks)
Rate of Infection Episodes (Serious and Non-serious) by Study Period, FAS Population(Up to 36 weeks)
Duration of Use of Antibiotics for Infection Prophylaxis and Treatment(Up to 36 weeks)
Rate of All Adverse Events by Relatedness and Seriousness(For the duration of the study, up to 36 weeks)
Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections by Study Period(Up to 36 weeks)
Rate of Mild, Moderate, or Severe Local Reactions(For the duration of the study, up to 36 weeks)