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: May 7, 2014
Last verified: May 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
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 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: May 7, 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 September 22, 2014