NCT07095478Not yet recruitingPhase 2
Safety and Efficacy of Oral Artesunate for Pre-cervical Cancer
Phase II Single Arm, Open Label Study of Artesunate for the Treatment of Human Papilloma Virus Positive High Grade Cervical Intraepithelial Neoplasia (CIN2/3)
Source: ClinicalTrials.gov · Last updated 31 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- First submitted
- 7 Jul 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Metanoic Health Ltd.
- Diseases
- Cervical cancer
- NCT number
- NCT07095478
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 28
- From 1 Aug 2025 to the primary completion date, 30 Jun 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- • Contraindication to the use of artesunate due to hypersensitivity
- Pregnancy or lactation
- Weight \< 52 kg
- History of previous CIN
- Immunocompromised patients
Who the study is looking for
- Aged 18 or over
- Histologically proven HPV positive cervical CIN2/3
- WHO performance status 0-2
- Adequate full blood count:
- White Cell Count (WCC) \>3.0 x 109 /l;
- Platelets \>100 x 109/l;
- Haemoglobin (Hb) \>80g/L
- Adequate renal function:
- Glomerular Filtration Rate \>30ml/min
- Adequate hepatobiliary function:
- Total bilirubin \< 3 x Upper limit normal
- Female participants of child bearing potential must have a negative pregnancy test \< 72 hours prior to initiating study intervention and agree to avoid pregnancy using adequate, medically approved contraceptive precautions for up to 6 weeks after the last dose of study treatment intervention
- Patient able and willing to provide written, informed consent for the study
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Ampang Coordinator of this site? Confirm its status | Ampang | Malaysia | Unknown status |
| Hospital Selayang Coordinator of this site? Confirm its status | Batu Caves | Malaysia | Unknown status |
| Pusat Perubatan Universiti Malaya Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| Hospital Umum Sarawak Coordinator of this site? Confirm its status | Kuching | Malaysia | Unknown status |
| Institut Kanser Negara Coordinator of this site? Confirm its status | Putrajaya | Malaysia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.