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NCT04722887 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Two Different Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Participants With Alpha1-Antitrypsin Deficiency
A Phase 1 study of Alpha-1 Antitrypsin Deficiency, sponsored by Grifols Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
- 5
- Study locations
NCT04722887: Completed Phase 1 study of Alpha-1 Antitrypsin Deficiency, sponsored by Grifols Therapeutics.
NCT04722887 is a Phase 1 study of Alpha-1 Antitrypsin Deficiency that has completed, run by Grifols Therapeutics. The registered enrollment target is 17 participants, below the 2,341-participant average among 24 other Alpha-1 Antitrypsin Deficiency trials with a reported enrollment target (99% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04722887, a Phase 1 study of Alpha-1 Antitrypsin Deficiency, has completed, sponsored by Grifols Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and tolerability of 72 milligrams per kilogram (mg/kg) and 180 mg/kg Alpha-1 15%, administered as a single-dose subcutaneous (SC) infusion and subsequently as weekly SC infusions over 8 weeks in participants with Alpha1-Antitrypsin Deficiency (AATD).
Conditions Studied
Interventions
- BIOLOGICAL Alpha-1 15%
- BIOLOGICAL Liquid Alpha1-Proteinase Inhibitor (Human)
Study Locations (5)
Florida
- University of Florida - Gainesville
- University of Miami - Miami
California
- UCLA Medical Center - Los Angeles
Ohio
- Cleveland Clinic - Cleveland
South Carolina
- Medical University of South Carolina - Children's Hospital - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2021-08-13 |
| Est. Completion | 2025-08-01 |
| Phase | Phase 1 |
What the finished NCT04722887 record still lists
NCT04722887 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 2,341-participant average among 24 other Alpha-1 Antitrypsin Deficiency trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Alpha-1 Antitrypsin Deficiency appearing as the primary indexed condition, and to 2 interventions - of which Alpha-1 15% is the first listed.
NCT04722887 lists 5 locations in 4 states (Florida, California, Ohio).
Frequently Asked Questions
What is clinical trial NCT04722887 about?
NCT04722887 is a clinical study titled "A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Two Different Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Participants With Alpha1-Antitrypsin Deficiency". The purpose of this study is to evaluate the safety and tolerability of 72 milligrams per kilogram (mg/kg) and 180 mg/kg Alpha-1 15%, administered as a single-dose subcutaneous (SC) infusion and subsequently as weekly SC infusions over 8 weeks in participants with Alpha1-Antitrypsin Deficiency (AATD...
What is the current status of trial NCT04722887?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2021-08-13. Estimated completion is 2025-08-01.
What conditions does trial NCT04722887 study?
This clinical trial studies the following conditions: Alpha-1 Antitrypsin Deficiency.
What interventions are being tested in trial NCT04722887?
The interventions under investigation include: Alpha-1 15% (BIOLOGICAL), Liquid Alpha1-Proteinase Inhibitor (Human) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04722887?
This trial is sponsored by Grifols Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04722887 being conducted?
This trial has 5 study locations across California, Florida, Ohio, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04722887's enrollment target sits among peer trials
17 19th of 24 higher than 6 of 24 other Alpha-1 Antitrypsin Deficiency trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alpha-1 Antitrypsin Deficiency trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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