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NCT05719311 · ClinicalTrials.gov registry record · Phase 2
Study to Assess an Enteric Microgranule Formulation of Adrulipase in Patients With Cystic Fibrosis
A Phase 2 study, sponsored by Entero Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT05719311 is a Phase 2 study that has completed, run by Entero Therapeutics. The registered enrollment target is 13 participants.
The verdict
NCT05719311, a Phase 2 study, has completed, sponsored by Entero Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
Some cystic fibrosis patients are unable to digest food and absorb nutrition appropriately as they have a condition known as exocrine pancreatic insufficiency (EPI). Currently, these patients take pancreatic enzymes that are obtained from pig pancreas to aid the digestion of food. The goals of this clinical study are to evaluate the safety and efficacy of a novel formulation of a non-porcine lipase, called adrulipase, in patients with EPI due to cystic fibrosis. The main question\[s\] the study aims to answer are: 1. Is the novel formulation of adrulipase safe to use at the doses being evaluated in the clinical study. 2. Is adrulipase as effective, or more effective, compared to the pig enzymes the patients currently use. Researchers will compare the results obtained with adrulipase to how the patients typically respond to their pig enzymes to see if adrulipase helps patients digest fats adequately and if their stomach feels good (signs and symptoms of malabsorption).
Interventions
- DRUG adrulipase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2023-02-01 |
| Est. Completion | 2023-07-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05719311
The ClinicalTrials.gov registry entry for NCT05719311 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 13 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 1 intervention - of which adrulipase is the first listed.
NCT05719311 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05719311 about?
NCT05719311 is a clinical study titled "Study to Assess an Enteric Microgranule Formulation of Adrulipase in Patients With Cystic Fibrosis". Some cystic fibrosis patients are unable to digest food and absorb nutrition appropriately as they have a condition known as exocrine pancreatic insufficiency (EPI). Currently, these patients take pancreatic enzymes that are obtained from pig pancreas to aid the digestion of food. The goals of this ...
What is the current status of trial NCT05719311?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2023-02-01. Estimated completion is 2023-07-28.
What interventions are being tested in trial NCT05719311?
The interventions under investigation include: adrulipase (DRUG).
Who is sponsoring clinical trial NCT05719311?
This trial is sponsored by Entero Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
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