Low grade cervical intraepithelial neoplasia (CIN) MedDRA version: 9.1 Level: LLT Classification code 10066238 Term: Cervical low grade squamous intraepithelial lesion
Conditions
Interventions
Product Name: Cevira
Product Code: P-1206
Pharmaceutical Form: Suppository
INN or Proposed INN: Hexyl aminolevulinate hydrochloride
CAS Number: 140898-91-5
Current Sponsor code: P-1206
Concentration u
Sponsors
Photocure ASA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Satisfactory colposcopy examination including: o visibility of entire transformation zone including the squamocolumnar junction and o visibility of entire lesion margin • Negative endocervical canal by colposcopy. • Pap III D as verified by local cytology or CIN1 as verified by local biopsy. • Colposcopical visible lesion at visit 2, before photoactivation. • Written Informed Consent signed • Age 18 or above Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Non-satisfactory colposcopy examination including o non-visibility of entire transformation zone including the squamocolumnar junction or o non-visibility of entire lesion margin • Previous treatment of CIN or invasive disease or suspicion of either micro-invasive or invasive disease • Malignant cells on cytology or histology • Atypical glandular cells (AGC) or adenocarcinoma in situ (AIS) on cytology • Suspicion of endocervical disease on colposcopy • Current pelvic inflammatory disease, cervicitis, or other gynecological infection as per colposcopy and clinical examination • Known or suspected porphyria • Patients who have received one or more shots of a prophylactic HPV vaccine (e.g.Gardasil or Cervarix) • Known allergy to hexaminolevulinate or similar compounds (e.g. methyl aminolevulinate or aminolevulinic acid) • Pregnancy • Nursing • Childbirth or miscarriage within six weeks of enrolment • Participation in other “competitive” clinical studies either concurrently or within the last 30 days • Risk of poor protocol compliance. Patient participation should be considered with respect to living far away from the hospital, plans for moving to another city/state, frequent traveling, planning to become pregnant, drug abuse/alcoholic, difficult working hours, family obligations, other illness (e.g. psychiatric), etc. • Not willing to use adequate birth control from screening until last PDT • Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare patient complete response rate of HAL PDT and placebo 6 months after last PDT in patients with low-grade cervical intraepithelial neoplasia (CIN). ;Secondary Objective: To evaluate patient safety of HAL PDT in patients with low-grade CIN. To compare complete response rate of HAL PDT and placebo 3 months after first PDT. To compare the eradication rate of HPV* genotype after HAL PDT and placebo 6 months after last PDT. * In this document HPV refers to high-risk HPV (HPV subtypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58 and 59). ;Primary end point(s): Percent of patients with complete response 6 months after last PDT. | — |
Countries
France, Germany
Outcome results
None listed