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NCT03746483 · ClinicalTrials.gov registry record · Phase 2
OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
A Phase 2 study, sponsored by Entero Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
NCT03746483: Completed Phase 2 study, sponsored by Entero Therapeutics.
NCT03746483 is a Phase 2 study that has completed, run by Entero Therapeutics. The registered enrollment target is 41 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03746483, a Phase 2 study, has completed, sponsored by Entero Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
Study 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).
Primary Outcome
The Coefficient of Fat Absorption (CFA%) is defined as: \[72-hour fat intake (g) - 72-hour fat excretion (g)/72-hour fat intake(g)\] x 100 = CFA% The threshold for CFA results (\>80%) is considered clinically significant for treatment effectiveness by the FDA.
Interventions
- DRUG MS1819
- DRUG Porcine PERT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2019-01-10 |
| Est. Completion | 2019-07-27 |
| Phase | Phase 2 |
What the finished NCT03746483 record still lists
NCT03746483 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 2 interventions - of which MS1819 is the first listed.
NCT03746483 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03746483 about?
NCT03746483 is a clinical study titled "OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis". 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).
What is the current status of trial NCT03746483?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2019-01-10. Estimated completion is 2019-07-27.
What interventions are being tested in trial NCT03746483?
The interventions under investigation include: MS1819 (DRUG), Porcine PERT (DRUG).
Who is sponsoring clinical trial NCT03746483?
This trial is sponsored by Entero Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03746483's enrollment target sits among peer trials
41 1352nd of 2000 higher than 639 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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