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NCT04375878 · ClinicalTrials.gov registry record · Phase 2
OPTION 2: A Trial to Assess the Safety and Efficacy of MS1819 in Enteric Capsules in Patients With Cystic Fibrosis
A Phase 2 study, sponsored by Entero Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT04375878: Completed Phase 2 study, sponsored by Entero Therapeutics.
NCT04375878 is a Phase 2 study that has completed, run by Entero Therapeutics. The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04375878, a Phase 2 study, has completed, sponsored by Entero Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
The primary objectives of this study are to assess the safety and efficacy of MS1819 in enteric capsules vs porcine pancreatic enzyme replacement therapy (PERT) in patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). The exploratory objective of the extension phase (EP) is to find a dose of MS1819 in immediate release capsules that is safe and results in CFA values in a therapeutic range.
Primary Outcome
Number of subjects reporting 1 or more adverse events
Interventions
- DRUG MS1819
- DRUG Porcine PERT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2020-07-20 |
| Est. Completion | 2021-04-08 |
| Phase | Phase 2 |
What the finished NCT04375878 record still lists
NCT04375878 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which MS1819 is the first listed.
NCT04375878 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04375878 about?
NCT04375878 is a clinical study titled "OPTION 2: A Trial to Assess the Safety and Efficacy of MS1819 in Enteric Capsules in Patients With Cystic Fibrosis". The primary objectives of this study are to assess the safety and efficacy of MS1819 in enteric capsules vs porcine pancreatic enzyme replacement therapy (PERT) in patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). The exploratory objective of the extension phase (EP)...
What is the current status of trial NCT04375878?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2020-07-20. Estimated completion is 2021-04-08.
What interventions are being tested in trial NCT04375878?
The interventions under investigation include: MS1819 (DRUG), Porcine PERT (DRUG).
Who is sponsoring clinical trial NCT04375878?
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 NCT04375878's enrollment target sits among peer trials
27 1697th of 2000 higher than 293 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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