Alveolar Echinococcosis: Parasite Viability and Innovative Markers for the Follow-up of Patients Treated With Albendazole (EchinoVISTA)
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|ClinicalTrials.gov Identifier: NCT02876146|
Recruitment Status : Active, not recruiting
First Posted : August 23, 2016
Last Update Posted : October 17, 2017
Study design to define improved management of patients with hepatic alveolar echinococcosis treated with albendazole and especially make appropriate and timely decision of treatment withdrawal .
Based on exploratory analysis of existing and newly developed biological and imaging exams, for diagnosis and follow-up, and study of the relationship of these markers to the viability of the parasite and/or the activity of the parasitic lesions The study included two series of patients: operated on (curative hepatectomy) // non-operated on
|Condition or disease||Intervention/treatment||Phase|
|Alveolar Echinococcosis||Drug: Benzimidazole||Not Applicable|
Close follow-up of the patients, based on WHO guidelines (Brunetti, Acta tropica 2010), including albendazole bloods levels determination.
Clinical exam, sampling and storing (biobank) of blood specimens at inclusion, M1, M3, M6, M9, M12, M18, M24, M30, M36, M44, M48.
Additional sampling for operated on patients : M15 and M21.
Imaging each year (US, CT, PET-CT & RMI).
Preservation of operative specimens samples at -80°C: samples taken at different location (center and periphery of the lesions) and in distant non-infected liver, for further studies of the immune response, RNA detection, and albendazole dosages.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Alveolar Echinococcosis: Parasite Viability and Innovative Markers for Follow-up of Patients Treated With Albendazole - EchinoVISTA Prospective Clinical Study|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2023|
Hepatic alveolar echinococcosis
Follow-up of standardized clinical, biological, and imaging characteristics (according to the WHO-expert consensus). Albendazole treatment, 400 mg x 2/d (or mebendazole if adverse effects)
Standardized earlier withdrawal of benzimidazole :
Withdrawal of benzimidazole after 4 years (non operable AE) or one year after surgery (curative hepatectomy)
Other Name: Standardized earlier withdrawal of albendazole
- Ratio of non-operated on patients with negative viability markers after a 4 years benzimidazole treatment [ Time Frame: 4 years after last inclusion ]
- Ratio of non-operated on patients without AE relapse after benzimidazole withdrawal [ Time Frame: 7 years after last inclusion ]Benzimidazole withdrawal after 4 years, then 3 years of close follow-up
- Ratio of operated on patients without AE relapse after benzimidazole withdrawal [ Time Frame: 3 years after last inclusion ]Benzimidazole withdrawal one year after surgery, then 3 years of close follow-up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02876146
|Study Chair:||Frédéric GRENOUILLET, PharmD, PhD||University Hospital Besançon|
|Principal Investigator:||Carine RICHOU, MD||University Hospital Besançon|