drugset / Trial / NCT02722304
Stage 1 Study of ARALAST NP and GLASSIA in A1PI Deficiency
Phase 3
Terminated
7 enrolled
Baxalta now part of Shire
Baxalta Innovations GmbH, now part of Shire · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to conduct a pilot study to evaluate the safety and efficacy of weekly administration of Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy in subjects with A1PI deficiency and emphysema/ chronic obstructive pulmonary disease (COPD).
Timeline
- Start
- 2016-11-02
- Primary completion
- 2018-09-14
- Completion
- 2018-09-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alpha 1-Antitrypsin | Protein / enzyme biologic | 60 mg/kg | — |
| Subject | Alpha 1-Antitrypsin | Protein / enzyme biologic | 120 mg/kg | — |