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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 Alpha1-Antitrypsin Deficiency, sponsored by Grifols Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
- 5
- Study locations
NCT04722887 is a Phase 1 study of Alpha1-Antitrypsin Deficiency that has completed, run by Grifols Therapeutics. The registered enrollment target is 17 participants, below the 157-participant average among 5 other Alpha1-Antitrypsin Deficiency trials with a reported enrollment target (89% lower). The trial reports 5 study locations across 4 states.
The verdict
NCT04722887, a Phase 1 study of Alpha1-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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04722887
The ClinicalTrials.gov registry entry for NCT04722887 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 157-participant average among 5 other Alpha1-Antitrypsin Deficiency trials with a reported enrollment target (89% lower). The listed sponsor is Grifols Therapeutics, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Alpha1-Antitrypsin Deficiency appearing as the primary indexed condition, and to 2 interventions - of which Alpha-1 15% is the first listed.
NCT04722887 reports 5 study locations spanning 4 distinct geographic areas - top geographies include 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: Alpha1-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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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