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

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

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).

Study Overview

• Status: Completed
• Conditions: Primary Immune Deficiency
• Intervention / Treatment: Biological: Immune globulin subcutaneous (Human)

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Aichi Pref.
    • Nagoya city, Aichi Pref., Japan, 466-8560
      • Study Site
  • Chiba Pref.
    • Chiba city, Chiba Pref., Japan, 260-8677
      • Study Site
  • Fukuoka
    • Fukuoka city, Fukuoka, Japan, 812-8582
      • Study Site
  • Gifu Pref.
    • Gifu city, Gifu Pref., Japan, 502-8558
      • Study Site
  • Hokkaido
    • Sapporo city, Hokkaido, Japan, 060-8648
      • Study Site
  • Osaka
    • Moriguchi city, Osaka, Japan, 570-8507
      • Study Site
  • Saitama Pref.
    • Koshigaya city, Saitama Pref., Japan, 343-8555
      • Study Site
    • Tokorozawa city, Saitama Pref., Japan, 359-8513
      • Study Site
  • Tokyo Metropolitan
    • Bunkyo-ku, Tokyo Metropolitan, Japan, 113-8519
      • Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 75 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: IgPro20	Biological: Immune globulin subcutaneous (Human); IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use.; Other Names: Hizentra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Annualized rate of infection episodes	Up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	SBIs are defined as bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess.	Up to 36 months
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

Collaborators and Investigators

• Sponsor: CSL Behring
• Investigators: Study Director: Yusuke Watanabe, CSL Behring K.K.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): July 1, 2014
• Study Completion (ACTUAL): July 1, 2014

Study Registration Dates

• First Submitted: October 24, 2011
• First Submitted That Met QC Criteria: October 26, 2011
• First Posted (ESTIMATE): October 27, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): December 2, 2014
• Last Update Submitted That Met QC Criteria: November 25, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Immune globulin subcutaneous; SCIG; Primary immunodeficiency; PID
• Additional Relevant MeSH Terms: Immune System Diseases; Genetic Diseases, Inborn; Immunologic Deficiency Syndromes; Primary Immunodeficiency Diseases; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous; gamma-Globulins; Rho(D) Immune Globulin
• Other Study ID Numbers: IgPro20_3006