Trials / Completed
CompletedNCT02282527
A Study to Assess Safety and PK of Liquid Alpha₁-Proteinase Inhibitor (Human) in Treating Alpha₁-Antitrypsin Deficiency
A Multi-center, Randomized, Double-blind, Crossover Study to Assess the Safety and Pharmacokinetics of Liquid Alpha₁-Proteinase Inhibitor (Human) Compared to Prolastin®-C in Subjects With Alpha₁-Antitrypsin Deficiency
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Grifols Therapeutics LLC · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
Grifols Therapeutics Inc. conducted a multi-center, randomized, double-blind, crossover study to evaluate the safety, immunogenicity, and pharmacokinetics (PK) of Liquid Alpha₁-PI compared to the currently licensed product, Prolastin-C, in subjects with Alpha₁-Antitrypsin Deficiency (AATD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Liquid Alpha₁-PI | Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions |
| BIOLOGICAL | Prolastin-C | Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2016-01-01
- Completion
- 2016-01-01
- First posted
- 2014-11-04
- Last updated
- 2017-03-13
- Results posted
- 2017-03-13
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02282527. Inclusion in this directory is not an endorsement.