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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.

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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.

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

FieldValue
Enrollment Target 30 participants
Start Date 2021-01-18
Est. Completion 2025-03
Phase Phase 2

Sponsor

Rapamycin Holdings

2 total trials

What the Registry Record Tells You About NCT04230499

The ClinicalTrials.gov registry entry for NCT04230499 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 246-participant average among 10 other Familial Adenomatous Polyposis trials with a reported enrollment target (88% lower). The listed sponsor is Rapamycin Holdings, which has 2 total studies on file at ClinicalTrials.gov.

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 4 study locations spanning 3 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.