An open-label study to evaluate the safety of weekly intravenous infusions of alpha1-proteinase inhibitor (human) with alpha1 antitrypsin deficiency (AATD)
Not Applicable
Completed
- Conditions
- Alpha1 antitrypsin deficiency
- Registration Number
- JPRN-jRCT2080225207
- Lead Sponsor
- Grifols Japan K.K.
- Brief Summary
ong-term weekly intravenous infusions of 60 mg/kg Alpha-1 MP are generally safe and well-tolerated in Japanese patients with AATD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 5
Inclusion Criteria
Subjects who didn't participate JapicCTI-163160 and whose serum alpha1 PI concentration is <50mg/d
Exclusion Criteria
Subjects who participated JapicCTI-163160
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Safety evaluation
- Secondary Outcome Measures
Name Time Method