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NCT00301366 · ClinicalTrials.gov registry record · Phase 3
The Safety and Tolerability of Alpha-1 Modified Process (MP) In Subjects With Alpha-1-antitrypsin (AAT) Deficiency
A Phase 3 study of Alpha-1 Antitrypsin Deficiency, sponsored by Grifols Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 38
- Enrollment target
- 10
- Study locations
NCT00301366: Completed Phase 3 study of Alpha-1 Antitrypsin Deficiency, sponsored by Grifols Therapeutics.
NCT00301366 is a Phase 3 study of Alpha-1 Antitrypsin Deficiency that has completed, run by Grifols Therapeutics. The registered enrollment target is 38 participants, below the 2,340-participant average among 24 other Alpha-1 Antitrypsin Deficiency trials with a reported enrollment target (98% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00301366, a Phase 3 study of Alpha-1 Antitrypsin Deficiency, has completed, sponsored by Grifols Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 38 participants
- Enrollment target
- 10
- Study locations
Study Summary
The purpose of this clinical study is to assess the safety and tolerability of Alpha-1 MP in adult Alpha1-antitrypsin deficient patients.
Primary Outcome
An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered with a pharmaceutical product. The adverse event does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the medicinal product.
Conditions Studied
Interventions
- DRUG alpha-1 proteinase inhibitor (human)
Study Locations (10)
Florida
- University of Florida College of Medicine - Gainesville
- University of Miami School of Medicine - Miami
Colorado
- National Jewish Medical and Research Center - Denver
New York
- St Lukes-Roosevelt Hospital Center, New York - New York
Ohio
- Cleveland Clinic Foundation - Cleveland
Pennsylvania
- Temple University Hospital - Philadelphia
South Carolina
- Medical University of South Carolina - Charleston
Texas
- University of Texas Health Center at Tyler - Tyler
England
- University of Cambridge - Cambridge Institute for Medical Research - Cambridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2006-06 |
| Est. Completion | 2007-03 |
| Phase | Phase 3 |
What the finished NCT00301366 record still lists
NCT00301366 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 2,340-participant average among 24 other Alpha-1 Antitrypsin Deficiency trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Alpha-1 Antitrypsin Deficiency appearing as the primary indexed condition, and to 1 intervention - of which alpha-1 proteinase inhibitor (human) is the first listed.
NCT00301366 lists 10 locations in 9 states (Florida, Colorado, New York).
Frequently Asked Questions
What is clinical trial NCT00301366 about?
NCT00301366 is a clinical study titled "The Safety and Tolerability of Alpha-1 Modified Process (MP) In Subjects With Alpha-1-antitrypsin (AAT) Deficiency". The purpose of this clinical study is to assess the safety and tolerability of Alpha-1 MP in adult Alpha1-antitrypsin deficient patients.
What is the current status of trial NCT00301366?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 38 participants. The study started on 2006-06. Estimated completion is 2007-03.
What conditions does trial NCT00301366 study?
This clinical trial studies the following conditions: Alpha-1 Antitrypsin Deficiency.
What interventions are being tested in trial NCT00301366?
The interventions under investigation include: alpha-1 proteinase inhibitor (human) (DRUG).
Who is sponsoring clinical trial NCT00301366?
This trial is sponsored by Grifols Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00301366 being conducted?
This trial has 10 study locations across Colorado, Florida, New York, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alpha-1 Antitrypsin Deficiency
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00301366's enrollment target sits among peer trials
38 16th of 24 higher than 9 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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