Status:
COMPLETED
Safety and Pharmacokinetics of Alpha-1 Proteinase Inhibitor in Subjects With Alpha1-Antitrypsin Deficiency
Lead Sponsor:
Grifols Therapeutics LLC
Conditions:
Emphysema
Alpha 1-antitrypsin Deficiency (AATD)
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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/k...
Detailed Description
The question of whether higher doses of alpha1-PI (\>60 mg/kg) are able to provide better protection to patients with alpha 1-antitrypsin deficiency is currently unknown. As a first step to address th...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01213043
Start Date
November 1 2010
End Date
January 1 2012
Last Update
May 20 2013
Active Locations (5)
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1
University of Florida College of Medicine
Gainesville, Florida, United States, 32610-0225
2
University of Miami
Miami, Florida, United States, 33136
3
Temple University Hosptial/Temple Lung Center
Philadelphia, Pennsylvania, United States, 19140
4
Medical University of South Carolina, Division of Pulmonary and Critical Care Medicine
Charleston, South Carolina, United States, 29425-6300