Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263887
Status:
COMPLETED
Last Update Posted:
2014-08-21
First Post:
2005-09-12
Brief Title:
Alpha-1-Antitrypsin AAT To Treat Emphysema In AAT-Deficient Patients EXACTLE
Sponsor:
Grifols Therapeutics LLC
Organization:
Grifols Therapeutics LLC
Study Overview
Official Title:
Multi-center Randomized Trial With IV Prolastin to Evaluate Frequency of Exacerbations and Progression of Emphysema by Means of Multi-slice CT Scans in Patients With Congenital Alpha-1-antitrypsin Deficiency
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this trial was to explore the utility of evaluating emphysema progression through CT scans measuring lung density during a 2 year period of weekly infusions of either placebo or human alpha-1-antitrypsin AAT Prolastin Exacerbation data recorded in patient diaries were also collected All efficacy data were analyzed for potential use in evaluating Prolastin efficacy in this and other clinical trials
Detailed Description:
This is a one to one randomized placebo-controlled clinical exploratory study with the aim of collecting information on possible clinical endpoints ie the progression of emphysema by lung density measurements with CT scan and frequency of exacerbations that could be used for a subsequent placebo controlled clinical trial Progression of disease will be investigated in 80 patients with alpha-1-antitrypsin deficiency who will be treated with human alpha-1-antitrypsin AAT Prolastin or placebo weekly for two years to analyze the effect of treatment on lung density and exacerbations Targeted augmentation therapy with weekly infusions of Prolastin will be a dose of 60 mgkg body weight range of 5172 to 7143 mg per kg body weight
Therefore this study focuses on several questions
Is the 15th percentile point calculated by analysis of CT lung histograms a useful endpoint for clinical trials in AAT deficiency
Is quantitation of exacerbations in AAT-deficient patients a useful endpoint for clinical trials in AAT deficiency
Are there significant differences between the treatments in favor of Prolastin
Therefore this study focuses on several questions
Is the 15th percentile point calculated by analysis of CT lung histograms a useful endpoint for clinical trials in AAT deficiency
Is quantitation of exacerbations in AAT-deficient patients a useful endpoint for clinical trials in AAT deficiency
Are there significant differences between the treatments in favor of Prolastin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None