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NCT07076446 · ClinicalTrials.gov registry record · Phase 4
An Open-label, Multicenter Study to Assess the Pharmacokinetics (PK), Safety, and Tolerability of Subcutaneous IgPro20 in Immunoglobulin (IG) Treatment-naïve Participants With Primary Immunodeficiency (PID)
A Phase 4 study of Primary Immunodeficiency, sponsored by CSL Behring.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 8
- Enrollment target
- 8
- Study locations
NCT07076446: Recruiting Phase 4 study of Primary Immunodeficiency, sponsored by CSL Behring.
NCT07076446 is a Phase 4 study of Primary Immunodeficiency that is actively recruiting participants, run by CSL Behring. The registered enrollment target is 8 participants, below the 5,838-participant average among 4 other Primary Immunodeficiency trials with a reported enrollment target (100% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07076446, a Phase 4 study of Primary Immunodeficiency, is actively recruiting participants, sponsored by CSL Behring.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 8 participants
- Enrollment target
- 8
- Study locations
Study Summary
This is an open-label, multicenter, phase 4 study in IG treatment-naïve participants with PID, conducted in the United States (US), to assess the PK, safety, and tolerability of IgPro20. The primary objective of this study is to characterize the PK of IgPro20 and to assess the safety and tolerability of IgPro20 in IG treatment-naïve participants with PID who are aged greater than or equal to (\>=) 18 years.
Conditions Studied
Interventions
- BIOLOGICAL IgPro
Study Locations (8)
Arizona
- Research Solutions of AZ - Litchfield Park
- Medical Research of Arizona - Scottsdale
Colorado
- Immunoe Health Centers - Centennial
Maryland
- Johns Hopkins Bayview Medical Center - Baltimore
Minnesota
- Midwest Immunology - Plymouth
Missouri
- Washington University - St Louis
Oklahoma
- Allergy, Asthma and Clinical Research Center - Oklahoma City
Pennsylvania
- Allergy & Clinical Immunology - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2025-07-15 |
| Est. Completion | 2026-05-04 |
| Phase | Phase 4 |
What NCT07076446 shows while recruiting
NCT07076446 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 5,838-participant average among 4 other Primary Immunodeficiency trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Primary Immunodeficiency appearing as the primary indexed condition, and to 1 intervention - of which IgPro is the first listed.
NCT07076446 lists 8 locations in 7 states (Arizona, Colorado, Maryland).
Frequently Asked Questions
What is clinical trial NCT07076446 about?
NCT07076446 is a clinical study titled "An Open-label, Multicenter Study to Assess the Pharmacokinetics (PK), Safety, and Tolerability of Subcutaneous IgPro20 in Immunoglobulin (IG) Treatment-naïve Participants With Primary Immunodeficiency (PID)". This is an open-label, multicenter, phase 4 study in IG treatment-naïve participants with PID, conducted in the United States (US), to assess the PK, safety, and tolerability of IgPro20. The primary objective of this study is to characterize the PK of IgPro20 and to assess the safety and tolerabilit...
What is the current status of trial NCT07076446?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 8 participants. The study started on 2025-07-15. Estimated completion is 2026-05-04.
What conditions does trial NCT07076446 study?
This clinical trial studies the following conditions: Primary Immunodeficiency.
What interventions are being tested in trial NCT07076446?
The interventions under investigation include: IgPro (BIOLOGICAL).
Who is sponsoring clinical trial NCT07076446?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07076446 being conducted?
This trial has 8 study locations across Arizona, Colorado, Maryland, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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