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ACTIVE NOT RECRUITING Phase 2

Trial of ERapa to Prevent Progression in Familial Adenomatous Polyposis Patients Under Active Surveillance

NCT04230499 · View on ClinicalTrials.gov ↗

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

30 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04230499

The ClinicalTrials.gov registry entry for NCT04230499 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rapamycin Holdings, which has 30 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04230499 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Ohio, Michigan, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04230499?

The interventions under investigation include: Encapsulated Rapamycin (eRapa) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04230499?

This trial is sponsored by Rapamycin Holdings, which has 30 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial