Last updated: October 3, 2023
Sponsor: Kazakh Association of Internal Medicine Specialists
Overall Status: Active - Recruiting
Phase
N/A
Condition
Liver Disease
Primary Biliary Cholangitis
Treatment
N/AClinical Study ID
NCT06078722
KAIMS-01
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients of both sexes aged 18 to 75 years, who are citizens of the Republic ofKazakhstan;
- Patients with a clinically and laboratory confirmed diagnosis of MAFLD, without severeconcomitant diseases;
- Patients who do not receive other adjuvant therapy (metabolic therapy drugs, essentialphospholipids, ursodeoxycholic acid, glycyrrhizic acid, ademetionine and others);
- Patients who have at least a 7-day gap between the end of other adjuvant therapy andthe start of COC and BDD;
- Patients who voluntarily signed the informed consent form.
Exclusion
Exclusion Criteria:
- Patients who abuse alcohol according to the AUDIT-c questionnaire;
- Patients taking COC for more than 4 weeks before signing the informed consent;
- Patients with contraindications to COC;
- Patients diagnosed with diabetes mellitus;
- Pregnancy and lactation;
- Simultaneous use of levodopa, altretamine, cisplatin, statins;
- Patients with coinfection with HIV, HBV, HCV;
- Decompensated liver cirrhosis CPT≥7 points;
- GFR ≤ 15 ml/min/1.73 m2;
- Drug-induced liver damage;
- Taking narcotic and psychotropic drugs;
- Malignant formations of the liver and other organs (in history and currently) or aclinically significant increase in alpha-fetoprotein more than >5 times;
- patients with pronounced biochemical activity (ALT, AST more than 10 ULN) and totalbilirubin more than 2 ULN;
- Participation in an interventional clinical trial.
Study Design
Total Participants: 264
Study Start date:
February 08, 2023
Estimated Completion Date:
February 08, 2025
Connect with a study center
State-owned public enterprise with the right of economic management "Enbekshikazakh Interdistrict Multidisciplinary Hospital"
Esik, Almaty Region
KazakhstanActive - Recruiting
LLP "InkarMed"
Aktobe,
KazakhstanActive - Recruiting
hepatology center on the basis of the State Public Enterprise at the RV "City Clinic No. 5"
Almaty,
KazakhstanActive - Recruiting
Medical Center "iClinic"
Astana,
KazakhstanActive - Recruiting
Non-profit joint-stock company "Semey Medical University"
Semey,
KazakhstanActive - Recruiting
Medical center "Gatromed"
Shymkent,
KazakhstanActive - Recruiting
State-owned public enterprise with the right of economic management "Regional Clinical Hospital" of the Department of Public Health of the Turkestan region
Turkestan,
KazakhstanActive - Recruiting
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