drugset / Trial / NCT03746483
OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
RandomizedCrossoverOpen-labelTreatment
Summary
The primary objectives of this study are to assess the safety and efficacy of MS1819-SD vs porcine pancreatic enzyme replacement therapy (PERT) in patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).
Timeline
- Start
- 2019-01-10
- Primary completion
- 2019-07-13
- Completion
- 2019-07-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MS1819 | Protein / enzyme biologic | 2240 mg | Oral |