CompletedPhase 1

Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection.

South Africa8 participantsStarted 2018-12-21

Plain-language summary

This study evaluates the use of ABI-1968, a topical cream, in the treatment of cervical precancerous lesions in females without human immunodeficiency virus (HIV) infection.

Who can participate

Age range25 Years – 50 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Women, 25 to 50 years old.
✓. Biopsy-confirmed cervical HSIL that is p16+ within 60 days of enrollment (dosing) with no evidence of invasive cancer in any specimen.
✓. Colposcopy is satisfactory based on visualization of the entire squamo-columnar junction (SCJ). The borders of all lesions must be completely visible.
✓. The upper limit of the visible (usually aceto-white) lesion is within 3 quadrants or less at screening.

Exclusion criteria

✕. Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females.
✕. HIV positive (tested at screening visit or within 3 months of screening visit).
✕. Resolution of visible CIN lesion prior to enrollment.
✕. ECC positive for glandular disease (adenocarcinoma in situ) or invasive cancer.
✕. History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of CIN, or hysterectomy.

What they're measuring

Safety & Tolerability of ABI-1968 for the treatment of cHSIL

Timeframe: 42 days

Trial details

NCT IDNCT03697226

SponsorAntiva Biosciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-05-26

View on ClinicalTrials.gov More HSIL of Cervix trials