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

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ClinicalTrials.gov Identifier: NCT01461018
Recruitment Status : Completed
First Posted : October 27, 2011
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Study Description
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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).

Condition or disease Intervention/treatment Phase
Primary Immune Deficiency Biological: Immune globulin subcutaneous (Human) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
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
Study Start Date : October 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

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Arms and Interventions
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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 Name: Hizentra


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

Secondary Outcome Measures :
  1. Number of subjects with adverse events (AEs) [ Time Frame: Up to 36 months ]
  2. Percentage of subjects with adverse events (AEs) [ Time Frame: Up to 36 months ]
  3. Rate of AEs per infusion [ Time Frame: Up to 36 months ]
  4. 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.

  5. 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 ]
  6. Number of days of hospitalization due to infections [ Time Frame: Up to 36 months ]
  7. Duration of use of antibiotics for infection prophylaxis and treatment [ Time Frame: Up to 36 months ]
  8. Median serum IgG concentration [ Time Frame: Up to 36 months ]

Eligibility Criteria
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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461018


Locations
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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
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Study Director: Yusuke Watanabe CSL Behring K.K.
More Information
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Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT01461018    
Other Study ID Numbers: IgPro20_3006
First Posted: October 27, 2011    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014
Keywords provided by CSL Behring:
Immune globulin subcutaneous
SCIG
Primary immunodeficiency
PID
Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulins
Antibodies
gamma-Globulins
 Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs