Status:
COMPLETED
The Safety and Tolerability of Alpha-1 Modified Process (MP) In Subjects With Alpha-1-antitrypsin (AAT) Deficiency
Lead Sponsor:
Grifols Therapeutics LLC
Conditions:
Alpha 1-Antitrypsin Deficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this clinical study is to assess the safety and tolerability of Alpha-1 MP in adult Alpha1-antitrypsin deficient patients.
Detailed Description
The objective of this clinical trial (STAMP: Safety and Tolerability of Alpha-1 Modified Process) is to study the safety and tolerability of Alpha-1 MP in adult Alpha 1-antitrypsin deficient subjects ...
Eligibility Criteria
Inclusion
- Documented diagnosis of congenital Alpha1-antitrypsin deficiency
- Documented forced expiratory volume in 1 second (FEV1 ) between 20% - 80% of predicted value within last 6 months.
- Signed written informed consent prior to initiation of any study related procedures.
Exclusion
- Females who are pregnant, breast feeding, or if of child-bearing potential, unwilling to practice adequate contraception throughout the study
- Use of systemic steroids within the 2 weeks prior to receiving study treatment (this does not include the use of inhaled steroids used on a routine or as needed basis).
- Subjects who have had exacerbations of their disease within one month of trial entry
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00301366
Start Date
June 1 2006
End Date
March 1 2007
Last Update
August 19 2014
Active Locations (10)
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1
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
2
University of Florida College of Medicine
Gainesville, Florida, United States, 32610-0225
3
University of Miami School of Medicine
Miami, Florida, United States, 33101
4
St Lukes-Roosevelt Hospital Center, New York
New York, New York, United States, 10019