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NCT03679598 · ClinicalTrials.gov registry record · Phase 2
Alvelestat (MPH966) for the Treatment of ALpha-1 ANTitrypsin Deficiency
A Phase 2 study of Emphysema or COPD and Alpha-1 Antitrypsin Deficiency (AATD), sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
- 10
- Study locations
NCT03679598: Completed Phase 2 study of Emphysema or COPD and Alpha-1 Antitrypsin Deficiency (AATD), sponsored by University of Alabama at Birmingham.
NCT03679598 is a Phase 2 study of Emphysema or COPD and Alpha-1 Antitrypsin Deficiency (AATD) that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 63 participants, roughly in line with the 65-participant average among 7 other Emphysema or COPD trials with a reported enrollment target. The trial reports 10 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03679598, a Phase 2 study of Emphysema or COPD and Alpha-1 Antitrypsin Deficiency (AATD), has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
- 10
- Study locations
Study Summary
This is a Phase 2, multicenter, double-blind, randomized (1:1), placebo-controlled, 12-week, proof-of-concept study to evaluate the safety and tolerability as well as the mechanistic effect of oral administration of alvelestat (MPH966) in subjects with confirmed AATD defined as Pi\*ZZ, Pi\*SZ, Pi\*null, or another rare phenotype/genotype known to be associated with either low (serum AAT level \<11 μM or \<57.2 mg/dL) or functionally impaired AAT including "F" or "I" mutations.
Primary Outcome
To evaluate the effect of alvelestat (MPH966) administered twice daily (bid) for 12 weeks on blood markers of within-individual % change in plasma desmosine/isodesmosine will be measured.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Alvelestat (MPH966)
Study Locations (10)
Alabama
- The University of Alabama at Birmingham Lung Health Center - Birmingham
California
- UCLA - Los Angeles
Colorado
- National Jewish Health - Denver
New York
- Columbia University - New York
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Ohio
- Cleveland Clinic - Cleveland
Pennsylvania
- Temple University - Philadelphia
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2019-04-08 |
| Est. Completion | 2023-12-01 |
| Phase | Phase 2 |
What the finished NCT03679598 record still lists
NCT03679598 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, roughly in line with the 65-participant average among 7 other Emphysema or COPD trials with a reported enrollment target.
The record links to 3 conditions, with Emphysema or COPD appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03679598 lists 10 locations in 10 states (Alabama, California, Colorado).
Frequently Asked Questions
What is clinical trial NCT03679598 about?
NCT03679598 is a clinical study titled "Alvelestat (MPH966) for the Treatment of ALpha-1 ANTitrypsin Deficiency". This is a Phase 2, multicenter, double-blind, randomized (1:1), placebo-controlled, 12-week, proof-of-concept study to evaluate the safety and tolerability as well as the mechanistic effect of oral administration of alvelestat (MPH966) in subjects with confirmed AATD defined as Pi\*ZZ, Pi\*SZ, Pi\*n...
What is the current status of trial NCT03679598?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2019-04-08. Estimated completion is 2023-12-01.
What conditions does trial NCT03679598 study?
This clinical trial studies the following conditions: Emphysema or COPD, Alpha-1 Antitrypsin Deficiency (AATD), Pi*ZZ, Pi*SZ, Pi*Null, Another Rare Phenotype/Genotype Known to be Associated With Either Low or Functionally Impaired AAT Including F or I Mutations.
What interventions are being tested in trial NCT03679598?
The interventions under investigation include: Placebo (OTHER), Alvelestat (MPH966) (DRUG).
Who is sponsoring clinical trial NCT03679598?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03679598 being conducted?
This trial has 10 study locations across Alabama, California, Colorado, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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