About this trial
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.
Eligibility criteria
Qualifiers
Aged 18 or over
Histologically proven HPV positive cervical CIN2/3
WHO performance status 0-2
White Cell Count (WCC) >3.0 x 109 /l;
Disqualifiers
• Contraindication to the use of artesunate due to hypersensitivity
Pregnancy or lactation
Weight < 52 kg
History of previous CIN
Trial design
Treatments tested in this trial
- Artesunate
Treatment groups
Sponsors and collaborators
Metanoic Health Ltd.
Lead sponsor
Clinical Research Malaysia
Collaborator