NCT00242385 - Pharmacokinetic Study of ARALAST (Human Alpha1- PI) | Biotech Hunter

Enrollment

25

Participants

Timeline

Start Date

December 20, 2005

Primary Completion Date

June 5, 2006

Study Completion Date

June 5, 2006

Conditions

Alpha 1-Antitrypsin Deficiency

Interventions

BIOLOGICAL

Dose of 60 mg/kg Fraction IV-1 Alpha1-Proteinase Inhibitor

Subjects meeting the eligibility criteria were randomized to receive either single dose ARALAST alpha1-proteinase inhibitor 60 mg/kg or single-dose ARALAST alpha1-proteinase inhibitor Fr. IV-1 60 mg/kg at 0.2 mL/kg/min during the first treatment period with crossover to the alternate study product during the second treatment period, with a minimum of 7 days between the two treatment periods.

BIOLOGICAL

Dose of 60 mg/kg alpha1-proteinase inhibitor

Subjects meeting the eligibility criteria were randomized to receive either single dose ARALAST alpha1-proteinase inhibitor 60 mg/kg or single-dose ARALAST alpha1-proteinase inhibitor Fr. IV-1 60 mg/kg at 0.2 mL/kg/min during the first treatment period with crossover to the alternate study product during the second treatment period, with a minimum of 7 days between the two treatment periods.

Trial Locations (7)

Unknown

Adelaide

Woodville

Fitzroy

Nedlands

Otahuhu

Christchurch

Hamilton