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

NCT03100045 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-11-03

No results posted yet for this study

Summary

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

Conditions

  • HPV-Related Anal Intraepithelial Neoplasia
  • AIN2/3
  • Artesunate
  • Alternative Treatment
  • Anal Dysplasia
  • Precancerous Conditions
  • Human Papilloma Virus

Interventions

DRUG

Artesunate Suppositories

Artesunate suppositories for the treatment of (AIN2/3) Anal Intraepithelial Neoplasia

Sponsors & Collaborators

  • Frantz Viral Therapeutics, LLC

    collaborator INDUSTRY

  • University of Wisconsin, Madison

    collaborator OTHER

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Sandy H Fang, MD · Johns Hopkins University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-20
Primary Completion
2021-10-06
Completion
2021-10-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03100045 on ClinicalTrials.gov