Alpha-1-Antitrypsin (AAT) To Treat Emphysema In AAT-Deficient Patients (EXACTLE)

PHASE2CompletedINTERVENTIONAL
Enrollment

77

Participants

Timeline

Start Date

December 31, 2003

Primary Completion Date

January 31, 2007

Study Completion Date

January 31, 2007

Conditions
Alpha 1-Antitrypsin Deficiency
Interventions
DRUG

Alpha1-Proteinase Inhibitor (Human)

Weekly infusion of 60 mg/kg body weight for 2 years

DRUG

Albumin (Human) 20%, United States Pharmacopeia (USP)

Weekly infusion for 2 years. Albumin (Human) 20% will be diluted with 5% glucose to a final concentration of 2.0%.

Trial Locations (3)

2900

Gentofte Hospital Department of Respiratory Medicine, Hellerup

Unknown

Department of Pulmonary Medicine, Malmö University Hospital, Malmo

B15 2TH

Queen Elizabeth Hospital, Birmingham

Sponsors
All Listed Sponsors
lead

Grifols Therapeutics LLC

INDUSTRY