Alveolar EchinococcosisPhase 2NCT07182305
Treatment Trial of Alveolar Echinococcosis
A Phase 2 study testing Efficacy of albendazole for early stage intervention of alveolar echinococcosis in people with Alveolar Echinococcosis, run by Ministry of Health, Kyrgyzstan at 1 site in Kyrgyzstan.
Trial summary
A new focus of subjects with lesions of alveolar echinococcosis caused by Echinococcus multilocularis has been found south of Gulcha in Osh province in Kyrgyzstan by an ultrasound surveillance. Prevalence of infections is approximately 6%. Most lesions are small. Read more about this study
- Who is it for?
- Ages 10 to 70 years
- Conditions the study is for
- Alveolar Echinococcosis
- What is being tested?
- Efficacy of albendazole for early stage intervention of alveolar echinococcosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteKyrgyzstan
- Study dates
- 1 May 2017to 31 Jul 2023
- Phase
- Phase 2
- 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 10 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Presence of lesion diagnosed by ultrasound that is consistent with early stage alveolar echinococcosis. Lesion less than 3 cm in diameter
Who cannot join
- Absence of lesion. Large lesion requiring surgical treatment
Trial locations and contacts
1 site in 1 country.
Kyrgyzstan1 site
Department of disease prevention and sanitary - epidemiological surveillance
Bishkek
About this study
Official title: Treatment Trial With Albendazole of Patients With a Diagnosis of Early Stage Alveolar Echinococcosis
A new focus of subjects with lesions of alveolar echinococcosis caused by Echinococcus multilocularis has been found south of Gulcha in Osh province in Kyrgyzstan by an ultrasound surveillance. Prevalence of infections is approximately 6%. Most lesions are small. Current scientific evidence suggests that in the absence of treatment, alveolar echinococcosis has a case fatality rate approaching 100% within 10-15 years of infection. Albendazole is known to be effective as a parasitostatic treatment to prolong the life of subjects with this disease, possibly up to normal life expectancy with prolonged treatment. The trial will be a case control study to evaluate the treatment of subjects with early stage alveolar echinococcosis and the progression of disease.
Read the detailed description
- case definition of patients with early stage alveolar echinococcosis. These are patients who are otherwise healthy, but have been identified as having hepatic lesions consistent with alveolar echinococcosis as diagnosed by ultrasound through a monitoring programme.
- Subjects will be randomised 60 patients into treatment and 60 into non treatment groups.
- Randomisation should be such that approximately similar age and gender profiles match in each group.
- Baseline examination by imaging. Define the lesion and case definition. Blood samples taken from all subjects at baseline
- Blood is analysed for serological evidence of echinococcosis
- Treatment is started. Treatment for case group is 2 x 400 mg Albendazole, daily. Control group has a placebo.
- Monitor at 2 weeks and 4 weeks for liver function, serology and imaging
- Monitor every 3 months thereafter.
- Subjects that have any evidence of lesion progression will be referred for surgical treatment regardless of treatment group.
- Monitoring for 2 years. Assess lesions in treatment and placebo groups. Assess dynamics of antibody (if any). Assess numbers of subjects from each group who have been referred for surgery following progression of lesion.
- Indicators for premature ending of trail would include evidence that the treatment is effective (ie treatment group not progressing or lesions regressing, whilst non treatment group lesions increase in size) - action all subjects now put into therapy.
No effect of albendazole - lesions progressing in all cases - indicating surgical treatment required in all cases.
Most lesions regressing in both the treatment and control group - indicates most early cases spontaneously resolve. Stop treatment but continue to monitor all cases.
- Conditions
- Alveolar Echinococcosis
- Being tested
- Efficacy of albendazole for early stage intervention of alveolar echinococcosis
- Keywords
- alveolar echinococcosis, Echinococcus multilocularis, albendazole
- Medical subject headings
- Alveolar echinococcosis, Echinococcosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efficacy of albendazole for early stage intervention of alveolar echinococcosisDrug
Participants in the treatment arm will be treated with albendazole, 2 x 400 mg daily for the duration of the study. Treatment may be prolonged beyond the end of the study if clinically appropriate.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Cases defined as early stage alveolar echinococcosis receive daily dose of albendazole 2 x 400 mg Receives: Drug: Efficacy of albendazole for early stage intervention of alveolar echinococcosis |
| Control | No intervention | Cases defined as early stage alveolar echinococcosis not receiving placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of parasitic lesion
Increase in size of lesion or regression or calcification. Participants will be regularly assessed using ultrasound imaging of the lesion. The lesion size will me measured. The size of the lesion was measured using the cross-sectional image with the longest diameter on ultrasound. The measurement will be in millimeters.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start1 May 2017
- Primary completion30 Apr 2021
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alveolar EchinococcosisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Kyrgyzstan
- Sponsor type
- Other government
- Collaborators
- University of Zurich
- Responsible party
- Principal investigator, Gulnara Minbaeva, Ministry of Health, Kyrgyzstan
- Investigators
- Gulnara Minbaeva, MD, Principal investigator, Department of disease prevention and sanitary - epidemiological surveillance, Ministry of Health of the Kyrgyz Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182305
- Sponsor's protocol ID
- AE-Kyrgyzstan
- Status last verified
- Sep 2025
- First submitted
- 22 May 2017
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be confidential or anonymised. Results will be published but no patient will be identifiable. Such will be freely available from mid 2019 and available between the trial investigators from the start of the trial
Publications
Minbaeva G, Tukeshov U, Aetbiev S, Usubaleava J, Abduldaeva G, Jumashava G, Mullhaupt B, Deibel A, Kronenberg PA, Deplazes P, Torgerson PR. Albendazole Treatment of Alveolar Echinococcosis in a Trial Based on a Cross Sectional Ultrasound Study in Kyrgyzstan. Trop Med Int Health. 2026 Sep 23. doi: 10.1111/tmi.70230. Online ahead of print.
PubMed 42778348
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Trial With Albendazole of Patients With a Diagnosis of Early Stage Alveolar Echinococcosis
- ClinicalTrials.gov ID
- NCT07182305
- Acronym / sponsor ID
- AE-Kyrgyzstan
- Conditions
- Alveolar Echinococcosis
- Keywords
- alveolar echinococcosis, Echinococcus multilocularis, albendazole
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Ministry of Health, KyrgyzstanOther government
- Collaborators
- University of Zurich
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 19 Sep 2025 (actual)
- 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.
A new focus of subjects with lesions of alveolar echinococcosis caused by Echinococcus multilocularis has been found south of Gulcha in Osh province in Kyrgyzstan by an ultrasound surveillance. Prevalence of infections is approximately 6%. Most lesions are small. Current scientific evidence suggests that in the absence of treatment, alveolar echinococcosis has a case fatality rate approaching 100% within 10-15 years of infection. Albendazole is known to be effective as a parasitostatic treatment to prolong the life of subjects with this disease, possibly up to normal life expectancy with prolonged treatment. The trial will be a case control study to evaluate the treatment of subjects with early stage alveolar echinococcosis and the progression of disease.
Detailed description
- case definition of patients with early stage alveolar echinococcosis. These are patients who are otherwise healthy, but have been identified as having hepatic lesions consistent with alveolar echinococcosis as diagnosed by ultrasound through a monitoring programme.
- Subjects will be randomised 60 patients into treatment and 60 into non treatment groups.
- Randomisation should be such that approximately similar age and gender profiles match in each group.
- Baseline examination by imaging. Define the lesion and case definition. Blood samples taken from all subjects at baseline
- Blood is analysed for serological evidence of echinococcosis
- Treatment is started. Treatment for case group is 2 x 400 mg Albendazole, daily. Control group has a placebo.
- Monitor at 2 weeks and 4 weeks for liver function, serology and imaging
- Monitor every 3 months thereafter.
- Subjects that have any evidence of lesion progression will be referred for surgical treatment regardless of treatment group.
- Monitoring for 2 years. Assess lesions in treatment and placebo groups. Assess dynamics of antibody (if any). Assess numbers of subjects from each group who have been referred for surgery following progression of lesion.
- Indicators for premature ending of trail would include evidence that the treatment is effective (ie treatment group not progressing or lesions regressing, whilst non treatment group lesions increase in size) - action all subjects now put into therapy.
No effect of albendazole - lesions progressing in all cases - indicating surgical treatment required in all cases.
Most lesions regressing in both the treatment and control group - indicates most early cases spontaneously resolve. Stop treatment but continue to monitor all cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Drug: Efficacy of albendazole for early stage intervention of alveolar echinococcosisCases defined as early stage alveolar echinococcosis receive daily dose of albendazole 2 x 400 mg |
| Control | No intervention | –Cases defined as early stage alveolar echinococcosis not receiving placebo treatment |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Presence of lesion diagnosed by ultrasound that is consistent with early stage alveolar echinococcosis. Lesion less than 3 cm in diameter
Key exclusion criteria (1 listed)
- Absence of lesion. Large lesion requiring surgical treatment
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 |
|---|---|---|
| Efficacy of albendazole for early stage intervention of alveolar echinococcosisParticipants in the treatment arm will be treated with albendazole, 2 x 400 mg daily for the duration of the study. Treatment may be prolonged beyond the end of the study if clinically appropriate. | Drug | Treatment |
Primary outcome
Progression of parasitic lesion
Time frame: 3 years
Increase in size of lesion or regression or calcification. Participants will be regularly assessed using ultrasound imaging of the lesion. The lesion size will me measured. The size of the lesion was measured using the cross-sectional image with the longest diameter on ultrasound. The measurement will be in millimeters.
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 19 Sep 2025.
- Derived from this study: PubMed 42778348Minbaeva G, Tukeshov U, Aetbiev S, Usubaleava J, Abduldaeva G, Jumashava G, Mullhaupt B, Deibel A, Kronenberg PA, Deplazes P, Torgerson PR. Albendazole Treatment of Alveolar Echinococcosis in a Trial Based on a Cross Sectional Ultrasound Study in Kyrgyzstan. Trop Med Int Health. 2026 Sep 23. doi: 10.1111/tmi.70230. Online ahead of print.
- Individual participant dataSharing planned: No. IPD will be confidential or anonymised. Results will be published but no patient will be identifiable. Such will be freely available from mid 2019 and available between the trial investigators from the start of the trial
Related trials for Alveolar Echinococcosis
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5G Remote Robotic Surgery for Hepatic Echinococcosis in High-Altitude Region
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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.
Gulnara Minbaeva, MD principal investigator
Department of disease prevention and sanitary - epidemiological surveillance, Ministry of Health of the Kyrgyz Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Efficacy of albendazole for early stage intervention of alveolar echinococcosis in people with Alveolar Echinococcosis, run by Ministry of Health, Kyrgyzstan at 1 site in Kyrgyzstan.
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 1 inclusion and 1 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 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kyrgyzstan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Progression of parasitic lesion (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07182305, which also lists 1 linked publication.
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 19 Sep 2025.