The Safety and Tolerability of Alpha-1 Modified Process (MP) In Subjects With Alpha-1-antitrypsin (AAT) Deficiency

Completed · Phase 3

Conditions studied: Alpha 1-Antitrypsin Deficiency

In brief

The purpose of this clinical study is to assess the safety and tolerability of Alpha-1 MP in adult Alpha1-antitrypsin deficient patients.

Key facts

Study ID

NCT00301366

Run by

Grifols Therapeutics LLC

People needed

38

Starts

2006-06-01

Expected to finish

2007-03-01

Last updated by the study team

2014-08-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• National Jewish Medical and Research Center — Denver, Colorado, United States
• University of Florida College of Medicine — Gainesville, Florida, United States
• University of Miami School of Medicine — Miami, Florida, United States
• St Lukes-Roosevelt Hospital Center, New York — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Texas Health Center at Tyler — Tyler, Texas, United States
• University of Cambridge - Cambridge Institute for Medical Research — Cambridge, England, United Kingdom
• University Teaching Hospital of Edinburgh — Edinburgh, Scotland, United Kingdom

Full record on ClinicalTrials.gov

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