E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with recurrrent external condylomata acuminata located at the following genital regions: labia minora and majora, introitus vaginae, clitoris, prepuce, glans penis, coronal sulcus and frenulum, perianal skin, perineal region, inguinal- and pubes region. |
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E.1.1.1 | Medical condition in easily understood language |
Patients with recurrent genital warts caused by human papilloma virus type 6 or 11. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010295 |
E.1.2 | Term | Condylomata acuminatum |
E.1.2 | System Organ Class | 100000016515 |
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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 |
Primary objective is to evaluate the efficacy of Gardasil® compared with placebo on the prevention of recurrence of condylomata acuminata. The primary endpoint is the recurrence rate of condylomata acuminata within 6 month after the third vaccination. Recurrence is defined as (1) the presence of new lesion(s) in the area which had been treated or within 1 cm near the previously treated area and/or (2) appearance of new warts/lesions on other genital sites. All recurrences are verified by biopsy and histology.
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E.2.2 | Secondary objectives of the trial |
To compare Gardasil® versus placebo with respect to: •Time to recurrence of condylomata acuminata from the day of administration of first vaccination up to 6 months after last vaccination •Incidence of HPV 6/11 related external condylomata acuminata •Presence (DNA) and biological activity (RNA) of HPV6/11 and other HPV types in condylomata acuminata at visit 1 to visit 4 •HPV specific immunological outcomes (HPV antibody at visit 1 to visit 4 and T-cell responses at visit 1, visit 3 and visit 4) •Associations between immunological and clinical outcomes •Safety and tolerability
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- External condylomata acuminata (at least one) defined as: condylomata acuminata, condylomata gigantea, keratotic genital warts, papular warty-like lesions within 6 months after removal of previously clinically diagnosed external condylomata acuminata (at least one) - Willingness for single session ablation by scissor snip excision, curettage, electrocautery or laser surgery - Age ≥ 18 - Ability of patient to understand character and individual consequences of the clinical trial - provision of written informed consent
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E.4 | Principal exclusion criteria |
- Contraindications to vaccination with Gardasil® according to the summary of product characteristics - HIV infection or other known immune deficiency disease or current treatment with immunosuppressive drugs - Syphilis (clinical features of first stage and second stage) - Previous treatment with Imiquimod within the last 30 days prior to visit 1 -Previous/concomitant treatment with any other immunomodulators within the last 90 days prior to visit 1 - Previous immunization with Gardasil® or Cervarix - Patients who are unlikely to adhere to the protocol - Participation in other ongoing clinical trials or during their observation period - Pregnancy (women of child bearing potential, WOCBP, will be asked before enrollment and visit 4, and a pregnancy urine test will be perofmed at visits 1-3 before study medication is applied)
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E.5 End points |
E.5.1 | Primary end point(s) |
Recurrence is defined as (1) the presence of new lesion(s) in the area which had been treated or (2) appearance of new warts on other genital sites. All recurrences are verified by biopsy and histology. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The primary endpoint is the recurrence rate of condylomata acuminata within 6 month after the third vaccination. |
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E.5.2 | Secondary end point(s) |
To compare Gardasil® versus placebo with respect to: - Time to recurrence of condylomata acuminata from the day of administration of first vaccination up to 6 months after last vaccination - Incidence of HPV 6/11 related external condylomata acuminata - Presence (DNA) and biological activity (RNA) of HPV6/11 and other HPV types in condylomata acuminata at visit 1 to visit 4 - HPV specific immunological outcomes (HPV antibody at visit 1 to visit 4 and T-cell responses at visit 1 and visit 4) - Associations between immunological and clinical outcomes - Safety and tolerability
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Time to recurrence of condylomata acuminata from the day of administration of first vaccination up to 6 months after last vaccination |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 9 |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 48 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 48 |
E.8.9.2 | In all countries concerned by the trial days | 0 |