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NCT01983241 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD)
A Phase 3 study of Pulmonary Emphysema in Alpha-1 PI Deficiency, sponsored by Grifols Therapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 345
- Enrollment target
- 20
- Study locations
NCT01983241: Active Phase 3 study of Pulmonary Emphysema in Alpha-1 PI Deficiency, sponsored by Grifols Therapeutics.
NCT01983241 is a Phase 3 study of Pulmonary Emphysema in Alpha-1 PI Deficiency that is active but no longer recruiting, run by Grifols Therapeutics. The registered enrollment target is 345 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01983241, a Phase 3 study of Pulmonary Emphysema in Alpha-1 PI Deficiency, is active but no longer recruiting, sponsored by Grifols Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 345 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multi-center, randomized, placebo-controlled, double blind clinical study to assess the efficacy and safety of two separate dose regimens of Alpha-1 MP versus placebo for 156 weeks (i.e., 3 years) using computed tomography (CT) of the lungs as the main measure of efficacy. The two Alpha-1 MP doses to be tested are 60 mg/kg and 120 mg/kg administered weekly by IV infusion for 156 weeks. The study consists of an optional pre-screening phase, Screening Phase, a 156-week Treatment Phase, and an End of Study Visit at Week 160.
Primary Outcome
Whole lung PD15 measured by CT scan
Conditions Studied
Interventions
- BIOLOGICAL Alpha-1 MP
- OTHER 0.9% Sodium Chloride for Injection, USP
Study Locations (20)
Florida
- Grifols Investigative Site - Gainesville
- Grifols Investigative Site - Leesburg
- Grifols Investigative Site - Miami
São Paulo
- Grifols Investigative Site - Santo André
- Grifols Investigative Site - São Paulo
- Grifols Investigative Site - São Paulo
Arizona
- Grifols Investigative Site - Phoenix
Missouri
- Grifols Investigative Site - St Louis
North Carolina
- Grifols Investigative Site - Wilmington
Oregon
- Grifols Investigative Site - Portland
Pennsylvania
- Grifols Investigative Site - Hershey
South Carolina
- Grifols Investigative Site - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 345 participants |
| Start Date | 2013-11 |
| Est. Completion | 2027-01 |
| Phase | Phase 3 |
What the registry record for NCT01983241 still lists
NCT01983241 is an interventional study that assigns participants to a tested intervention. The registered 345 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Pulmonary Emphysema in Alpha-1 PI Deficiency appearing as the primary indexed condition, and to 2 interventions - of which Alpha-1 MP is the first listed.
NCT01983241 names 20 study sites across 16 states, led by Florida, São Paulo, Arizona.
Frequently Asked Questions
What is clinical trial NCT01983241 about?
NCT01983241 is a clinical study titled "Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD)". This is a multi-center, randomized, placebo-controlled, double blind clinical study to assess the efficacy and safety of two separate dose regimens of Alpha-1 MP versus placebo for 156 weeks (i.e., 3 years) using computed tomography (CT) of the lungs as the main measure of efficacy. The two Alpha-1 ...
What is the current status of trial NCT01983241?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 345 participants. The study started on 2013-11. Estimated completion is 2027-01.
What conditions does trial NCT01983241 study?
This clinical trial studies the following conditions: Pulmonary Emphysema in Alpha-1 PI Deficiency.
What interventions are being tested in trial NCT01983241?
The interventions under investigation include: Alpha-1 MP (BIOLOGICAL), 0.9% Sodium Chloride for Injection, USP (OTHER).
Who is sponsoring clinical trial NCT01983241?
This trial is sponsored by Grifols Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01983241 being conducted?
This trial has 20 study locations across Arizona, Florida, Missouri, North Carolina, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01983241's enrollment target sits among peer trials
345 1050th of 2000 higher than 951 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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