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

This study has been completed.
Information provided by (Responsible Party):
CSL Behring Identifier:
First received: October 24, 2011
Last updated: November 25, 2014
Last verified: November 2014
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: Intervention Model: Single Group Assignment
Masking: None (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

Resource links provided by NLM:

Further study details as provided by CSL Behring:

Primary Outcome Measures:
  • Annualized rate of infection episodes [ Time Frame: Up to 36 months ]

Secondary Outcome Measures:
  • 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 ]
    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 ]
  • 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 ]

Enrollment: 22
Study Start Date: October 2011
Study Completion Date: July 2014
Primary Completion Date: July 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


Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01461018

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
Study Director: Yusuke Watanabe CSL Behring K.K.
  More Information

Responsible Party: CSL Behring Identifier: NCT01461018     History of Changes
Other Study ID Numbers: IgPro20_3006
Study First Received: October 24, 2011
Last Updated: November 25, 2014

Keywords provided by CSL Behring:
Immune globulin subcutaneous
Primary immunodeficiency

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017