drugset / Trial / NCT00500084
Phase III ALTU-135 CP Safety Trial
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is an open-label, single-arm clinical study investigating the long-term safety of ALTU-135 treatment in Chronic Pancreatitis (CP) patients with exocrine Pancreatic Insufficiency (PI).
Timeline
- Start
- 2007-12
- Primary completion
- 2009-03
- Completion
- 2009-03
Outcome
Outcome not reported
Stopped (Business): “Sponsor decision.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Liprotamase | Protein / enzyme biologic | 3750 unknown | Oral |
| Subject | Liprotamase | Protein / enzyme biologic | 25000 unknown | Oral |
| Subject | Liprotamase | Protein / enzyme biologic | 32500 unknown | Oral |