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NCT04230499 · ClinicalTrials.gov registry record · Phase 2
Trial of ERapa to Prevent Progression in Familial Adenomatous Polyposis Patients Under Active Surveillance
A Phase 2 study of Familial Adenomatous Polyposis, sponsored by Rapamycin Holdings.
- Active
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 4
- Study locations
NCT04230499: Active Phase 2 study of Familial Adenomatous Polyposis, sponsored by Rapamycin Holdings.
NCT04230499 is a Phase 2 study of Familial Adenomatous Polyposis that is active but no longer recruiting, run by Rapamycin Holdings. The registered enrollment target is 30 participants, below the 246-participant average among 10 other Familial Adenomatous Polyposis trials with a reported enrollment target (88% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04230499, a Phase 2 study of Familial Adenomatous Polyposis, is active but no longer recruiting, sponsored by Rapamycin Holdings.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 4
- Study locations
Study Summary
Patients with Familial Adenomatous Polyposis (FAP) who are undergoing endoscopic surveillance will be given Encapsulated Rapamycin (eRapa) at one of three escalating doses/schedules for 12 months with the aim of reducing polyp burden.
Primary Outcome
Safety and tolerability of eRapa as determined by graded toxicity assessed throughout the trial per CTCAE v5.0.
Conditions Studied
Interventions
- DRUG Encapsulated Rapamycin (eRapa)
Study Locations (4)
Ohio
- Cleveland Clinic - Cleveland
- Ohio State University - Columbus
Michigan
- Michigan Medicine - Ann Arbor
Texas
- UT Health - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-01-18 |
| Est. Completion | 2025-03 |
| Phase | Phase 2 |
What the registry record for NCT04230499 still lists
NCT04230499 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 246-participant average among 10 other Familial Adenomatous Polyposis trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Familial Adenomatous Polyposis appearing as the primary indexed condition, and to 1 intervention - of which Encapsulated Rapamycin (eRapa) is the first listed.
NCT04230499 reports a single indexed study location in Ohio, Michigan, Texas.
Frequently Asked Questions
What is clinical trial NCT04230499 about?
NCT04230499 is a clinical study titled "Trial of ERapa to Prevent Progression in Familial Adenomatous Polyposis Patients Under Active Surveillance". Patients with Familial Adenomatous Polyposis (FAP) who are undergoing endoscopic surveillance will be given Encapsulated Rapamycin (eRapa) at one of three escalating doses/schedules for 12 months with the aim of reducing polyp burden.
What is the current status of trial NCT04230499?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2021-01-18. Estimated completion is 2025-03.
What conditions does trial NCT04230499 study?
This clinical trial studies the following conditions: Familial Adenomatous Polyposis.
What interventions are being tested in trial NCT04230499?
The interventions under investigation include: Encapsulated Rapamycin (eRapa) (DRUG).
Who is sponsoring clinical trial NCT04230499?
This trial is sponsored by Rapamycin Holdings, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04230499 being conducted?
This trial has 4 study locations across Michigan, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04230499's enrollment target sits among peer trials
30 10th of 10 higher than 1 of 10 other Familial Adenomatous Polyposis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Familial Adenomatous Polyposis 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.
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