E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Albendazole is an orally administered broad-spectrum anthelmintic Drug used in treatment of human alveolar and cystic echinococcosis. To date, data on albendazole and tissue pharmacokinetics are limited. The aim of the present study is to measure albendazole levels in plasma, cystic tissue and fluid by ex-vivo microdialysis following concurrent therapy with albendazole prior scheduled surgery. This will contribute to a more complete understanding of the drug’s penetration to its site of action. |
|
E.1.1.1 | Medical condition in easily understood language |
patients with dogs- and fox tapeworm infection, who receive albendazole prior to surgery |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Parasitic Diseases [C03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
• To obtain pharmacokinetic data of albendazole in plasma, cystic tissue and intra-cystic fluid of echinococcus cysts after the administration of albendazole prior to surgery |
|
E.2.2 | Secondary objectives of the trial |
• Pharmacokinetic (PK) calculations and comparison to currently discussed breakpoints • Collection of safety data of albendazole |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Cohort A only: - Confirmed Cystic Echinococcosis based on WHO criteria
Cohort B only: - Confirmed Alveolar Echinococcosis based on WHO criteria
Both cohorts: - Male or Female, Age above 18 years - Weight: > 60kg - Indication for cystectomy - Indication for therapy with albendazole prior to surgery - Active stages only (CE 2-3, WHO Informal Working Group on Echinococcosis standardized ultrasound classification of echinococcal cysts) - A signed and dated written informed consent form - The subject can understand and willing to comply with protocol requirements and timetables, instructions and protocol-stated restrictions
|
|
E.4 | Principal exclusion criteria |
• < 18 years of age • Patients not willing to participate in the study • Contraindication against albendazole or any ingredient • Positive serology in Screening (Virology) • Severe bleeding disorder • Pregnancy |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- penetration ratio calculated as tissue concentration (Cτ) divided by plasma concentration - area under the concentration time curve (AUC) from zero to last observed concentration (AUC0-τ), AUC from zero to infinity (AUC0-∞), maximum drug concentration (Cmax), half-life (t1/2), time to reach maximum drug concentration (tmax) in plasma
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
end of study day and final examination |
|
E.5.2 | Secondary end point(s) |
collection of adverse events during study participation |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
end of study day and final examination |
|
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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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
|
|
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 | |
E.8.9.1 | In the Member State concerned days | |