NCT03100045

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

A Phase I Study of Intra-Anally Administered Artesunate in Patients With High-Grade Anal Intraepithelial Neoplasia (AIN 2/3)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Patients diagnosed with AIN 2/3 will be enrolled sequentially in treatment cohorts receiving different doses of Artesunate suppositories administered trans-anally. Doses of escalation will be 200 mg, 400 mg, and 600 mg. Treatment cohorts will consist of 2 or 3 cycles at each dose level. Suppositories will be administered daily for 5 days. Five days constitutes 1 cycle. Up to 3 cycles will be administered at Weeks 0, 2, and 4.

Conditions

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

Interventions

Type	Name	Description
DRUG	Artesunate Suppositories	Artesunate suppositories for the treatment of (AIN2/3) Anal Intraepithelial Neoplasia

Timeline

• Start date: 2017-04-20
• Primary completion: 2021-10-06
• Completion: 2021-10-06
• First posted: 2017-04-04
• Last updated: 2021-11-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study