Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT07182305
Status:
COMPLETED
Last Update Posted:
2025-09-19
First Post:
2017-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment Trial of Alveolar Echinococcosis
Sponsor:
Ministry of Health, Kyrgyzstan
Organization:
Study Overview
Official Title:
Treatment Trial With Albendazole of Patients With a Diagnosis of Early Stage Alveolar Echinococcosis
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: