Safety and Pharmacokinetics of Alpha-1 Proteinase Inhibitor in Subjects With Alpha1-Antitrypsin Deficiency

PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 30, 2010

Primary Completion Date

January 31, 2012

Study Completion Date

January 31, 2012

Conditions
EmphysemaAlpha 1-antitrypsin Deficiency (AATD)
Interventions
BIOLOGICAL

Prolastin-C, 60 mg/kg

60 mg/kg weekly infusion of Prolastin-C for 8 weeks

BIOLOGICAL

Prolastin-C, 120 mg/kg

120 mg/kg weekly infusion of Prolastin-C for 8 weeks

Trial Locations (5)

19140

Temple University Hosptial/Temple Lung Center, Philadelphia

33136

University of Miami, Miami

75708

The University of Texas Health Science Center at Tyler, Tyler

32610-0225

University of Florida College of Medicine, Gainesville

29425-6300

Medical University of South Carolina, Division of Pulmonary and Critical Care Medicine, Charleston

Sponsors
All Listed Sponsors
lead

Grifols Therapeutics LLC

INDUSTRY