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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
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief Summary:

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

Drug Information available for: Albendazole

Arm Intervention/treatment
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 :

  • Patients with non operable hepatic AE lesion : Withdrawal of benzimidazole treatment for patients without metastasis or neighbouring lesions (PxN0M0) after at least 4 years when viability markers became negative (PET-CT, serological markers)
  • Curative hepatectomy : Earlier withdrawal of benzimidazole treatment for patients without metastasis or neighbouring lesions (PxN0M0) after one year (WHO guidelines : 2 years), if viability markers became negative. Close prospective follow-up after withdrawal (PET-CT, serological markers)
Drug: Benzimidazole
Withdrawal of benzimidazole after 4 years (non operable AE) or one year after surgery (curative hepatectomy)
Other Name: Standardized earlier withdrawal of albendazole




Primary Outcome Measures :
  1. Ratio of non-operated on patients with negative viability markers after a 4 years benzimidazole treatment [ Time Frame: 4 years after last inclusion ]

Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hepatic alveolar echinococcosis
  • without antiparasitic treatment or with antiparasitic treatment and hepatectomy programmed

Exclusion Criteria:

  • Patients with exclusively extra-hepatic form of alveolar echinococcosis
  • Women without effective contraception (Contraindication to benzimidazoles)
  • The immunosuppressed patients or receiving an immunosuppressive treatment will not be the object of a stop of the post-operative treatment by albendazole on 1 year after the intervention of radical resection; they can be included in the study but will receive the albendazole during 2 years; this exclusion applies to the patients treated by liver transplant.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Study Chair: Frédéric GRENOUILLET, PharmD, PhD University Hospital Besançon
Principal Investigator: Carine RICHOU, MD University Hospital Besançon
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02876146    
Other Study ID Numbers: R/2011/41
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
Albendazole
Benzimidazole
Echinococcus multilocularis
Alveolar echinococcosis
Liver Diseases
Additional relevant MeSH terms:
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Echinococcosis
Cestode Infections
Helminthiasis
Parasitic Diseases
Albendazole
Benzimidazole
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents