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Safety and Efficacy of Oral Artesunate for Pre-cervical Cancer
Sponsor: Metanoic Health Ltd.
Summary
NeoART-CIN is a Phase II clinical study evaluating the safety and effectiveness of oral artesunate in patients with pre-cancerous cervical intra-epithelial neoplasia (CIN2/3), to investigate if a course of treatment with oral artesunate can reverse pre-cancerous changes in the cervix and prevent the development and progression of invasive cancer. Findings from this study will increase our understanding of the effects of artesunate on CIN2/3 and if confirmatory inform future clinical studies.
Official title: Phase II Single Arm, Open Label Study of Artesunate for the Treatment of Human Papilloma Virus Positive High Grade Cervical Intraepithelial Neoplasia (CIN2/3)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
28
Start Date
2025-08-01
Completion Date
2028-06-30
Last Updated
2025-07-31
Healthy Volunteers
No
Conditions
Interventions
Artesunate
Patients with HPV positive CIN2/3 will receive 3 cycles of oral artesunate 200mg OD prior to standard of care therapeutic LLETZ. Each 21 day treatment cycle will comprise oral artesunate 200mg OD for 14 days followed by a 7 day treatment break.
Locations (5)
Pusat Perubatan Universiti Malaya
Kuala Lumpur, Kuala Lumpur, Malaysia
Institut Kanser Negara
Putrajaya, Kuala Lumpur, Malaysia
Hospital Umum Sarawak
Kuching, Sarawak, Malaysia
Hospital Ampang
Ampang, Selangor, Malaysia
Hospital Selayang
Batu Caves, Selangor, Malaysia