drugset / Trial / NCT03385395
Study Comparing Weekly Intravenous Administration of OctaAlpha1 With a Marketed Preparation Glassia® in Subjects With Alpha-1-antitrypsin Deficiency
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This randomized trial is being conducted to show non-inferiority of OctaAlpha1 compared to Glassia® in terms of the serum trough levels at steady state. This will be conducted in individuals with alpha-1-antitrypsin deficiency and clinical evidence of emphysema.
Timeline
- Start
- 2018-07
- Primary completion
- 2019-12
- Completion
- 2019-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Alpha 1-Antitrypsin | Protein / enzyme biologic | 60 mg/kg | Intravenous |
| Subject | OctaAlpha1 | Unknown | 60 mg/kg | Intravenous |