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Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)

Information source: CSL Behring
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Primary Immune Deficiency Disorder

Intervention: Immune globulin subcutaneous (Human) (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: CSL Behring

Official(s) and/or principal investigator(s):
Midori Kobayashi, Study Director, Affiliation: CSL Behring K.K.


The objective of this study is to assess the long-term safety, tolerability, and efficacy of IgPro20 in subjects with primary immunodeficiency (PID) as a follow-up to the pivotal study ZLB06_002CR (NCT01199705).

Clinical Details

Official title: A Multicenter Follow-up Study of Long-term Safety, Tolerability, and Efficacy of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Median of the Individual Subject's Rate of Adverse Events (AEs) Per Infusion

Secondary outcome:

Overall Rate of AEs Per Infusion

Number of Subjects With Newly Developing or Worsening AEs

Percentage of Infusions With Subject-assessed Tolerability of at Least 'Good'

IgG Trough Level

Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs)

Number of Infection Episodes (Serious and Non-serious)

Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections.

Number of Days of Hospitalization Due to Infections.

Duration of Use of Antibiotics for Infection Prophylaxis and Treatment


Minimum age: N/A. Maximum age: 75 Years. Gender(s): Both.


Inclusion Criteria:

- Subjects who have participated in study ZLB06_002CR and who have tolerated IgPro20


- Written informed consent by the subject/parent/legally acceptable representative.

Written assent for an underage subject (≥7 years at the time of obtaining informed consent), as far as possible. Exclusion Criteria:

- Ongoing serious bacterial infections (SBIs) (pneumonia, bacteremia/septicemia,

osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time of the first infusion.

- Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (known total urine

protein concentration >0. 2 g/L or urine protein ++ by dipstick).

- Pregnancy or nursing mother.

- Participation in a study with an investigational medicinal product (IMP) within 3

months prior to enrollment except for ZLB06_002CR.

- Subjects who are planning to donate blood during the study.

- Re-entry of subjects previously participating in the current follow-up study.

- Known or suspected antibodies to the IMP, or to excipients of the IMP.

Locations and Contacts

Study site, Nagoya city, Aichi Pref. 466-8560, Japan

Study site, Chiba city, Chiba Pref. 260-8677, Japan

Study site, Fukuoka city, Fukuoka 812-8582, Japan

Study site, Gifu city, Gifu Pref. 502-8558, Japan

Study site, Sapporo city, Hokkaido 060-8648, Japan

Study site, Moriguchi city, Osaka 570-8507, Japan

Study site, Koshigaya city, Saitama Pref. 343-8555, Japan

Study site, Tokorozawa city, Saitama Pref. 359-8513, Japan

Study site, Bunkyo-ku, Tokyo Metropolitan 113-8519, Japan

Additional Information

Starting date: April 2011
Last updated: February 27, 2013

Page last updated: August 23, 2015

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