Alveolar EchinococcosisEchinoVISTANCT02876146
Alveolar Echinococcosis: Parasite Viability and Innovative Markers for the Follow-up of Patients Treated With Albendazole
A study testing Benzimidazole in people with Alveolar Echinococcosis, run by Centre Hospitalier Universitaire de Besancon.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alveolar Echinococcosis
- What is being tested?
- Benzimidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hepatic alveolar echinococcosis
- without antiparasitic treatment or with antiparasitic treatment and hepatectomy programmed
Who cannot join
- 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.
About this study
Official title: Alveolar Echinococcosis: Parasite Viability and Innovative Markers for Follow-up of Patients Treated With Albendazole - EchinoVISTA Prospective Clinical Study
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
Read the 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.
- Conditions
- Alveolar Echinococcosis
- Being tested
- Benzimidazole
- Keywords
- Albendazole, Benzimidazole, Echinococcus multilocularis, Alveolar echinococcosis, Liver Diseases
- Medical subject headings
- Alveolar echinococcosis, Echinococcosis, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenzimidazoleDrug
Also called Standardized earlier withdrawal of albendazole
Withdrawal of benzimidazole after 4 years (non operable AE) or one year after surgery (curative hepatectomy)
| Study group | Role | What they receive |
|---|---|---|
| Hepatic alveolar echinococcosis | Other | 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) Receives: Drug: Benzimidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of non-operated on patients with negative viability markers after a 4 years benzimidazole treatment
Measured: 4 years after last inclusion
Secondary outcomes (2)
Ratio of non-operated on patients without AE relapse after benzimidazole withdrawal
Benzimidazole withdrawal after 4 years, then 3 years of close follow-up
Measured: 7 years after last inclusion
Ratio of operated on patients without AE relapse after benzimidazole withdrawal
Benzimidazole withdrawal one year after surgery, then 3 years of close follow-up
Measured: 3 years after last inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startJun 2012
- Primary completionAug 2021
- Study completionAug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar EchinococcosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric GRENOUILLET, PharmD, PhD, Study chair, University Hospital BesançonCarine RICHOU, MD, Principal investigator, University Hospital Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876146
- Sponsor's protocol ID
- R/2011/41
- Acronym
- EchinoVISTA
- Status last verified
- Oct 2017
- First submitted
- 16 Aug 2016
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar Echinococcosis: Parasite Viability and Innovative Markers for Follow-up of Patients Treated With Albendazole - EchinoVISTA Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT02876146
- Acronym / sponsor ID
- EchinoVISTA / R/2011/41
- Conditions
- Alveolar Echinococcosis
- Keywords
- Albendazole, Benzimidazole, Echinococcus multilocularis, Alveolar echinococcosis, Liver Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Aug 2021 (actual)
- Study completion
- Aug 2021 (actual)
- First posted
- 23 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatic alveolar echinococcosis | Other | Drug: BenzimidazoleFollow-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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- hepatic alveolar echinococcosis
- without antiparasitic treatment or with antiparasitic treatment and hepatectomy programmed
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BenzimidazoleAlso: Standardized earlier withdrawal of albendazoleWithdrawal of benzimidazole after 4 years (non operable AE) or one year after surgery (curative hepatectomy) | Drug | Hepatic alveolar echinococcosis |
Primary outcome
Ratio of non-operated on patients with negative viability markers after a 4 years benzimidazole treatment
Time frame: 4 years after last inclusion
2 secondary outcomes
Ratio of non-operated on patients without AE relapse after benzimidazole withdrawal
Time frame: 7 years after last inclusion
Ratio of operated on patients without AE relapse after benzimidazole withdrawal
Time frame: 3 years after last inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric GRENOUILLET, PharmD, PhD study chair
University Hospital Besançon
Carine RICHOU, MD principal investigator
University Hospital Besançon
Questions about this trial
What is this clinical trial studying?
A study testing Benzimidazole in people with Alveolar Echinococcosis, run by Centre Hospitalier Universitaire de Besancon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of non-operated on patients with negative viability markers after a 4 years benzimidazole treatment (time frame: 4 years after last inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021.