Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study)

Phase 3

Completed

• Conditions: Primary Immune Deficiency
• Interventions: Biological: Immune globulin subcutaneous (Human)

• Registration Number: NCT01461018
• Lead Sponsor: CSL Behring

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-24
• Study First Submitted QC: 2011-10-26
• Study First Posted: 2011-10-27
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-25
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IgPro20	Immune globulin subcutaneous (Human)	-

Primary Outcome Measures

Name	Time	Method
Annualized rate of infection episodes	Up to 36 months

Secondary Outcome Measures

Name	Time	Method
Number of subjects with adverse events (AEs)	Up to 36 months
Percentage of subjects with adverse events (AEs)	Up to 36 months
Rate of AEs per infusion	Up to 36 months
Annualized rate of clinically documented serious bacterial infections (SBIs)	Up to 36 months	SBIs are defined as bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess.
Number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections	Up to 36 months
Number of days of hospitalization due to infections	Up to 36 months
Duration of use of antibiotics for infection prophylaxis and treatment	Up to 36 months
Median serum IgG concentration	Up to 36 months

Trial Locations

Locations (2)

Study site; 🇯🇵 Bunkyo-ku, Tokyo Metropolitan, Japan

Study Site; 🇯🇵 Sapporo city, Hokkaido, Japan