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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 is a Phase 2 study that has completed, run by Entero Therapeutics. The registered enrollment target is 27 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04375878
The ClinicalTrials.gov registry entry for NCT04375878 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Entero Therapeutics, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which MS1819 is the first listed.
NCT04375878 reports 0 study locations.
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.
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