Safety and Pharmacokinetics of Alpha-1 Proteinase Inhibitor in Subjects With Alpha1-Antitrypsin Deficiency
Completed · Phase 2
Conditions studied: Emphysema, Alpha 1-antitrypsin Deficiency (AATD)
In brief
This is a study to assess the safety and pharmacokinetics of weekly infusions of 120 mg/kg of Prolastin-C (alpha1-proteinase inhibitor \[alpha1-PI\] \[Human\]), compared to weekly infusions of 60 mg/kg of Prolastin-C in patients with alpha 1-antitrypsin deficiency (AATD).
Key facts
- Study ID
- NCT01213043
- Run by
- Grifols Therapeutics LLC
- People needed
- 30
- Starts
- 2010-11-01
- Expected to finish
- 2012-01-01
- Last updated by the study team
- 2013-05-20
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Be between 18 and 70 years of age
- Have a documented diagnosis of congenital AATD
- Have a post-bronchodilator Forced Expired Volume in 1 second (FEV1) of ≥30% and <80% and FEV1/forced vital capacity (FVC) <70%
- If receiving alpha-1 PI augmentation therapy, be willing to discontinue the treatment for the duration of the study
You may not qualify if…
- Had a moderate or severe pulmonary exacerbation during the 4 weeks before the study
- History of lung or liver transplant
- Any lung surgery during the past 2 years
- Confirmed liver cirrhosis
- Elevated liver enzymes
- Severe concurrent disease
- Females who are pregnant or breast-feeding or unwilling to practice effective contraception during the study
- Infection with hepatitis A, B, or C, human immunodeficiency or parvovirus B19
- Smoking during the past 6 months
- Use of systemic steroids within 4 weeks of the study
- Use of antibiotics for an exacerbation within 4 weeks of the study
Where it is running
- University of Florida College of Medicine — Gainesville, Florida, United States
- University of Miami — Miami, Florida, United States
- Temple University Hosptial/Temple Lung Center — Philadelphia, Pennsylvania, United States
- Medical University of South Carolina, Division of Pulmonary and Critical Care Medicine — Charleston, South Carolina, United States
- The University of Texas Health Science Center at Tyler — Tyler, Texas, United States
Full record on ClinicalTrials.gov
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