Phase I/II Multicenter, Open-label Trial to Evaluate the Safety and Pharmacokinetics of Alpha-1 MP in Patients with Alpha1-Antitrypsin Deficiency
Phase 1
- Conditions
- Alpha1-antitrypsin deficiency
- Registration Number
- JPRN-jRCT2080223105
- Lead Sponsor
- Grifols Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 3
Inclusion Criteria
Main inclusion criteria:
- Subjects with clinically apparent pulmonary emphysema diagnosed by CT scan
- Subjects with serum alpha1-PI levels of <50 mg/dL
- Subjects whose percentage of force expired volume in 1 second/Forced vital capacity (FEV1/FVC) after inhalation of a bronchodilator is <70 %
Exclusion Criteria
Main exclusion criteria:
- Subjects with moderately or severely deteriorated lung function within 4 weeks
- Subjects whose percentage of forced expired volume in 1 second (%FEV1) after inhalation of a bronchodilator is <30%
- Subjects who have undergone lung transplantation or liver transplantation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety
- Secondary Outcome Measures
Name Time Method Pharmacokinetics