Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)
- Conditions
- Primary Immune DeficiencyTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2014-003609-14-Outside-EU/EEA
- Lead Sponsor
- CSL Behring
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 23
- Subjects who have participated in study ZLB06_002CR and who have tolerated IgPro20 well.
- 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 12
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 11
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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).;Secondary Objective: Not applicable.;Primary end point(s): Median of the Individual Subject's Rate of Adverse Events (AEs) Per Infusion;Timepoint(s) of evaluation of this end point: 24 weeks
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: 24 weeks;Secondary end point(s): - Overall Rate of AEs Per Infusion <br>- Number of Subjects With Newly Developing or Worsening AEs <br>- Percentage of Infusions With Subject-assessed Tolerability of at Least 'Good' <br>- IgG Trough Level <br>- Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs) <br>- Number of Infection Episodes <br>- Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections.<br>- Number of Days of Hospitalization Due to Infections<br>- Duration of Use of Antibiotics for Infection Prophylaxis and Treatment <br>