Overview

This trial is active, not recruiting.

Condition primary immune deficiency
Treatment immune globulin subcutaneous (human)
Phase phase 3
Sponsor CSL Behring
Start date October 2011
End date June 2014
Trial size 22 participants
Trial identifier NCT01461018, IgPro20_3006

Summary

The purpose of this study is to assess the long-term efficacy, tolerability, and safety of IgPro20 in subjects with primary immunodeficiency (PID) as an extension to the preceding follow-up study ZLB07_001CR (NCT01458171).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
immune globulin subcutaneous (human) Hizentra
IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use.

Primary Outcomes

Measure
Annualized rate of infection episodes
time frame: Up to 36 months

Secondary Outcomes

Measure
Number of subjects with adverse events (AEs)
time frame: Up to 36 months
Percentage of subjects with adverse events (AEs)
time frame: Up to 36 months
Rate of AEs per infusion
time frame: Up to 36 months
Annualized rate of clinically documented serious bacterial infections (SBIs)
time frame: Up to 36 months
Number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections
time frame: Up to 36 months
Number of days of hospitalization due to infections
time frame: Up to 36 months
Duration of use of antibiotics for infection prophylaxis and treatment
time frame: Up to 36 months
Median serum IgG concentration
time frame: Up to 36 months

Eligibility Criteria

Male or female participants up to 75 years old.

Inclusion Criteria: - Subjects who have completed the preceding follow-up study ZLB07_001CR. - Written informed consent by the subject/parent/legally acceptable representative. Written assent for an underage subject (≥7 years and <20 years of age at the time of obtaining informed consent), according to the competencies of the subject. Exclusion Criteria: - Pregnancy or nursing mother. - Participation in a study with an investigational medicinal product (IMP) within 3 months prior to enrollment except for study ZLB07_001CR. - Subjects who are planning to donate blood during the study. - Known or suspected antibodies to the IMP, or to excipients of the IMP. - Treatment with another immunoglobulin G (IgG) within 3 months prior to the study.

Additional Information

Official title A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects With Primary Immunodeficiency
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by CSL Behring.