Trials Sponsors Conditions Drugs Pricing

Conditions

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

Keywords

HPVsuppositoryArtesunateartemisininanal dysplasiatreatmentalternative treatmentanal precancerJohns HopkinsSandy FangFrantz Viral TherapeuticsWisconsinEvie Carchman

Outcome Measures

Primary Outcomes (1)

Incidence of treatment-emergent adverse events (Safety and tolerability) of Artesunate suppositories for the treatment of anal intraepithelial neoplasia (AIN2/3)
Number of patients with serious adverse events or dose limiting toxicities related to the study medication, according to CTCAE4.0
6 weeks from the date of the first dosing

Secondary Outcomes (3)

Number of patients with histologic regression of anal intraepithelial neoplasia (AIN2/3) to AIN1 or less
16 weeks
Number of patients with histologic regression of anal intraepithelial neoplasia (AIN2/3) to AIN1 or less
28 weeks

Study Arms (6)

ART 200 mg, 2 cycles

EXPERIMENTAL

Two five-day cycles of Artesunate suppositories, 200 mg/day

Drug: Artesunate Suppositories

ART 200 mg, 3 cycles

EXPERIMENTAL

Three five-day cycles of Artesunate suppositories, 200 mg/day

Drug: Artesunate Suppositories

ART 400 mg, 2 cycles

EXPERIMENTAL

Two five-day cycles of Artesunate suppositories, 400 mg/day

Drug: Artesunate Suppositories

Interventions

Artesunate SuppositoriesDrug

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

Also known as: Artemisinin

ART 200 mg, 2 cyclesART 200 mg, 3 cyclesART 400 mg, 2 cyclesART 400 mg, 3 cyclesART 600 mg, 2 cyclesART 600 mg, 3 cycles

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 100 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age ≥ 18 years
Biopsy-confirmed high-grade anal dysplasia (AIN 2, AIN 3, HSIL) by high resolution anoscopy (HRA)

Sponsors & Collaborators

Frantz Viral Therapeutics, LLC
Industrycollaborator
University of Wisconsin, Madison
Othercollaborator
Johns Hopkins University

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

MeSH Terms

Conditions

Precancerous Conditions

Interventions

artemisinin

Condition Hierarchy (Ancestors)

Neoplasms

Study Officials

Sandy H Fang, MD
Johns Hopkins University
PRINCIPAL INVESTIGATOR

Enrollment

18 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 29, 2017

First Posted

April 4, 2017

Study Start

April 20, 2017

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (6)

ART 200 mg, 2 cycles

ART 200 mg, 3 cycles

ART 400 mg, 2 cycles

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

ART 400 mg, 3 cycles

ART 600 mg, 2 cycles

ART 600 mg, 3 cycles

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (6)

ART 200 mg, 2 cycles

ART 200 mg, 3 cycles

ART 400 mg, 2 cycles

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

ART 400 mg, 3 cycles

ART 600 mg, 2 cycles

ART 600 mg, 3 cycles

You may not qualify if:

Data Sharing

Source record

Locations