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CompletedNCT07182305Updated Sep 19, 2025

Treatment Trial of Alveolar Echinococcosis

A Phase 2 interventional study of Efficacy of albendazole for early stage intervention of alveolar echinococcosis in Alveolar Echinococcosis, sponsored by Ministry of Health, Kyrgyzstan. Completed at 1 site in Kyrgyzstan. Open to participants aged 10 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-09-19.

Sponsored by Ministry of Health, Kyrgyzstan · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
194
Allocation
Randomized
Ages
10 Years to 70 Years
Sex
All
01

Study 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. 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
  1. 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.
  2. Subjects will be randomised 60 patients into treatment and 60 into non treatment groups.
  3. Randomisation should be such that approximately similar age and gender profiles match in each group.
  4. Baseline examination by imaging. Define the lesion and case definition. Blood samples taken from all subjects at baseline
  5. Blood is analysed for serological evidence of echinococcosis
  6. Treatment is started. Treatment for case group is 2 x 400 mg Albendazole, daily. Control group has a placebo.
  7. Monitor at 2 weeks and 4 weeks for liver function, serology and imaging
  8. Monitor every 3 months thereafter.
  9. Subjects that have any evidence of lesion progression will be referred for surgical treatment regardless of treatment group.
  10. 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.
  11. 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.

02

Conditions studied

  • Alveolar Echinococcosis

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Keywords

  • alveolar echinococcosis
  • Echinococcus multilocularis
  • albendazole
03

In context

Echinococcosis

25 studies on the registry are indexed under Echinococcosis; 4 are open to participants now.

Browse Echinococcosis studies →

Lead sponsor

This is the only study on the registry with Ministry of Health, Kyrgyzstan as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Presence of lesion diagnosed by ultrasound that is consistent with early stage alveolar echinococcosis. Lesion less than 3 cm in diameter

Exclusion criteria

Exclusion Criteria:

  • Absence of lesion. Large lesion requiring surgical treatment
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
194 participants (actual)

Study arms

  • Active comparator
    Treatment

    Cases defined as early stage alveolar echinococcosis receive daily dose of albendazole 2 x 400 mg

    Drug: Efficacy of albendazole for early stage intervention of alveolar echinococcosis

  • No intervention
    Control

    Cases defined as early stage alveolar echinococcosis not receiving placebo treatment

Interventions

  • DrugEfficacy of albendazole for early stage intervention of alveolar echinococcosis

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 years

07

Study locations

1 site
  • Department of disease prevention and sanitary - epidemiological surveillance
    Bishkek, Kyrgyzstan
08

References and documents

Individual participant data

Plan to share: 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

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2017 to primary completion in Apr 2021, 47 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 22, 2017
First posted
Sep 19, 2025
StartActual
May 1, 2017
Primary completionActual
Apr 30, 2021
CompletionActual
Jul 31, 2023
Last update
Sep 19, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07182305
Lead sponsor
Ministry of Health, Kyrgyzstan
Responsible party
Gulnara Minbaeva (Epidemiologist, Ministry of Health, Kyrgyzstan) — Principal investigator
First posted
Sep 19, 2025
Start date
May 1, 2017
Primary completion
Apr 30, 2021
Completion
Jul 31, 2023
Last update
Sep 19, 2025

Study contacts

Gulnara Minbaeva, MD
principal investigator · Department of disease prevention and sanitary - epidemiological surveillance, Ministry of Health of the Kyrgyz Republic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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