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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT01461018
First received: October 24, 2011
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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).


Condition Intervention Phase
Primary Immune Deficiency
Biological: Immune globulin subcutaneous (Human)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects With Primary Immunodeficiency

Further study details as provided by CSL Behring:

Primary Outcome Measures:
  • Annualized rate of infection episodes [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of subjects with adverse events (AEs) [ Time Frame: Up to 36 months ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with adverse events (AEs) [ Time Frame: Up to 36 months ] [ Designated as safety issue: Yes ]
  • Rate of AEs per infusion [ Time Frame: Up to 36 months ] [ Designated as safety issue: Yes ]
  • Annualized rate of clinically documented serious bacterial infections (SBIs) [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]
  • Number of days of hospitalization due to infections [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]
  • Duration of use of antibiotics for infection prophylaxis and treatment [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]
  • Median serum IgG concentration [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: October 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Hizentra

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01461018

Locations
Japan
Study site
Nagoya city, Aichi Pref., Japan, 466-8560
Study site
Chiba city, Chiba Pref., Japan, 260-8677
Study site
Fukuoka city, Fukuoka, Japan, 812-8582
Study site
Gifu city, Gifu Pref., Japan, 502-8558
Study Site
Sapporo city, Hokkaido, Japan, 060-8648
Study site
Moriguchi city, Osaka, Japan, 570-8507
Study site
Koshigaya city, Saitama Pref., Japan, 343-8555
Study site
Tokorozawa city, Saitama Pref., Japan, 359-8513
Study site
Bunkyo-ku, Tokyo Metropolitan, Japan, 113-8519
Sponsors and Collaborators
CSL Behring
Investigators
Study Director: Yusuke Watanabe CSL Behring K.K.
  More Information

No publications provided

Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT01461018     History of Changes
Other Study ID Numbers: IgPro20_3006
Study First Received: October 24, 2011
Last Updated: March 17, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by CSL Behring:
Immune globulin subcutaneous
SCIG
Primary immunodeficiency
PID

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Immune System Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014