E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Low grade cervical intraepithelial neoplasia (CIN) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066238 |
E.1.2 | Term | Cervical low grade squamous intraepithelial lesion |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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). |
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E.2.2 | Secondary objectives of the trial |
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).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Percent of patients with complete response 6 months after last PDT.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
No treatment, only follow-up |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last patient included into the study is depending on how many treatments the last patient needs. If 1 treatment, the total time in the study is 6 months. If 2 treatments or only followy-up, the total time in the study is 10 months. So in theory, the last patient included into the trial might have the last visit earlier than some of the patients included earlier. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |