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NCT01669421 · ClinicalTrials.gov registry record · Phase 2
Effect of Double Dose of Alpha 1-antitrypsin Augmentation Therapy on Lung Inflammation.
A Phase 2 study of Alpha-1 Antitrypsin Deficiency, sponsored by Michael Campos, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT01669421 is a Phase 2 study of Alpha-1 Antitrypsin Deficiency that has completed, run by Michael Campos, MD. The registered enrollment target is 10 participants, below the 3,077-participant average among 18 other Alpha-1 Antitrypsin Deficiency trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01669421, a Phase 2 study of Alpha-1 Antitrypsin Deficiency, has completed, sponsored by Michael Campos, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
The current treatment of individuals with alpha-1 antitrypsin deficiency (AATD) who develop lung disease (COPD) is the administration of intravenous purified alpha-1 antitrypsin (augmentation therapy) at a fixed dose of 60 mg/kg per week. This dose aims at increasing the deficient AAT serum levels just above a predetermined "safety threshold" of 11 uM. However, normal levels of AAT are between 25-50 uM. AAT has shown not only to inhibit lung proteases such as neutrophil elastase, but also to modulate inflammation. Given that many subjects with AATD who receive augmentation therapy still have significant lung disease and inflammation, this study will evaluate whether doubling the dose to 120 mg/kg/week has an effect in decreasing lung inflammation. Only the dosing of 60 mg/kg /week has received FDA approval. FDA has granted an IND number to this study to test the higher dose of 120 mg/kg/week. The study will evaluate systemic (serum) and pulmonary (bronchoscopy samples)markers of inflammation in 3 phases: standard dose (4 weeks), double dose (4 weeks) and standard dose (4 weeks).
Conditions Studied
Interventions
- DRUG Alpha-1 Antitrypsin (human)
Study Locations (1)
Florida
- Division of Pulmonary and Critical Care, Human Reseach, U of Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2012-07 |
| Est. Completion | 2016-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01669421
The ClinicalTrials.gov registry entry for NCT01669421 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,077-participant average among 18 other Alpha-1 Antitrypsin Deficiency trials with a reported enrollment target (100% lower). The listed sponsor is Michael Campos, MD, which has 1 total studies on file at ClinicalTrials.gov.
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 Antitrypsin (human) is the first listed.
NCT01669421 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT01669421 about?
NCT01669421 is a clinical study titled "Effect of Double Dose of Alpha 1-antitrypsin Augmentation Therapy on Lung Inflammation.". The current treatment of individuals with alpha-1 antitrypsin deficiency (AATD) who develop lung disease (COPD) is the administration of intravenous purified alpha-1 antitrypsin (augmentation therapy) at a fixed dose of 60 mg/kg per week. This dose aims at increasing the deficient AAT serum levels j...
What is the current status of trial NCT01669421?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2012-07. Estimated completion is 2016-05.
What conditions does trial NCT01669421 study?
This clinical trial studies the following conditions: Alpha-1 Antitrypsin Deficiency.
What interventions are being tested in trial NCT01669421?
The interventions under investigation include: Alpha-1 Antitrypsin (human) (DRUG).
Who is sponsoring clinical trial NCT01669421?
This trial is sponsored by Michael Campos, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01669421 being conducted?
This trial has 1 study location across Florida. 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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