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

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Grifols Therapeutics Inc.; Grifols Therapeutics LLC
• Treatments: Alpha 1-Antitrypsin; Protease Inhibitors; Protein C Inhibitor

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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