NCT01461018CompletedPhase 3
A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects With Primary Immunodeficiency
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- CSL Behring
- Enrollment
- 22
- Locations
- 11
- Primary Endpoint
- Annualized rate of infection episodes
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 75 Years (Child, Adult, Older Adult)
- Sex
- 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.
Outcomes
Primary Outcomes
Annualized rate of infection episodes
Time Frame: Up to 36 months
Secondary Outcomes
- Number of subjects with adverse events (AEs)(Up to 36 months)
- Percentage of subjects with adverse events (AEs)(Up to 36 months)
- Rate of AEs per infusion(Up to 36 months)
- Annualized rate of clinically documented serious bacterial infections (SBIs)(Up to 36 months)
- Number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections(Up to 36 months)
- Number of days of hospitalization due to infections(Up to 36 months)
- Duration of use of antibiotics for infection prophylaxis and treatment(Up to 36 months)
- Median serum IgG concentration(Up to 36 months)
Investigators
Study Sites (11)
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