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NCT03100045 · ClinicalTrials.gov registry record · Phase 1

Intra-Anally Administered Artesunate in Patients With High-Grade Anal Intraepithelial Neoplasia (AIN 2/3)

A Phase 1 study, sponsored by Johns Hopkins University.

Completed
Registry status
Phase 1
Development phase
18
Enrollment target

NCT03100045: Completed Phase 1 study, sponsored by Johns Hopkins University.

NCT03100045 is a Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT03100045, a Phase 1 study, has completed, sponsored by Johns Hopkins University.

COMPLETED
Registry status
Phase 1
Development phase
18 participants
Enrollment target

Study Summary

This open label study investigates a novel non-surgical approach to the treatment of HPV-associated anal intraepithelial neoplasia, using Artesunate suppositories.

Primary Outcome

Number of patients with serious adverse events or dose limiting toxicities related to the study medication, according to CTCAE4.0

Interventions

  • DRUG Artesunate Suppositories

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2017-04-20
Est. Completion 2021-10-06
Phase Phase 1
Johns Hopkins University

1,448 total trials

What the finished NCT03100045 record still lists

NCT03100045 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).

The record links to 0 conditions, and to 1 intervention - of which Artesunate Suppositories is the first listed.

NCT03100045 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03100045 about?

NCT03100045 is a clinical study titled "Intra-Anally Administered Artesunate in Patients With High-Grade Anal Intraepithelial Neoplasia (AIN 2/3)". This open label study investigates a novel non-surgical approach to the treatment of HPV-associated anal intraepithelial neoplasia, using Artesunate suppositories.

What is the current status of trial NCT03100045?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2017-04-20. Estimated completion is 2021-10-06.

What interventions are being tested in trial NCT03100045?

The interventions under investigation include: Artesunate Suppositories (DRUG).

Who is sponsoring clinical trial NCT03100045?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03100045's enrollment target sits among peer trials

18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03100045, the US trial registry maintained by the National Library of Medicine. NCT03100045 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.