Evaluation of the Effectiveness of the Complex of Carnitine Orotate and Biphenyl Dimethyl Dicarboxylate in the Adjuvant Therapy of Chronic Hepatitis D in Real Clinical Practice: a Prospective Cohort Study
- Conditions
- Chronic Viral Hepatitis B With Delta-Agent
- Registration Number
- NCT06068140
- Lead Sponsor
- Kazakh Association of Internal Medicine Specialists
- Brief Summary
The goal of this observational study is to evaluate the effectiveness of the carnitine-orotate complex and biphenyl dimethyl dicarboxylate in the adjuvant therapy of chronic hepatitis D in real clinical practice: a prospective cohort study
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Patients of both sexes aged 18 to 75 years who are citizens of the Republic of Kazakhstan;
- An established diagnosis of CGD (chronic viral hepatitis B with the delta agent);
- Patients who have contraindications to taking peg-INF-alpha2a and/or have failed treatment with peg-INF-alpha2a;
- Compensated liver disease ≤ CPT A (6 points);
- Patients without severe concomitant diseases;
- Patients who do not receive other adjuvant therapy (metabolic therapy drugs, essential phospholipids, ursodeoxycholic acid, glycyrrhizic acid, ademetionine and others);
- Patients who voluntarily signed the informed consent form.
- Patients taking COC for more than 4 weeks before inclusion in the study;
- Patients with contraindications to the COC;
- Decompensated liver disease severity class > CPT A6;
- Patients taking peg-IFN-alpha 2a;
- Alcohol abuse according to the AUDIT-c questionnaire;
- Pregnancy and lactation;
- Patients with coinfection with HIV, HCV;
- GFR ≤ 15 ml/min/1.73 m2;
- Exclude patients with significant biochemical activity (ALT, AST more than 10 ULN) and total bilirubin more than 2 norms;
- Patients with other causes of liver damage;
- Drug addict people;
- Malignant formations of the liver and other organs (in history and currently) or a clinically significant increase in alpha-fetoprotein more than 5 times or more;
- Patient takes part in an interventional clinical trial.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Normalization of ALT levels during adjuvant CGD therapy at 12 months among study participants taking and not taking COC and BDD at 12 months
- Secondary Outcome Measures
Name Time Method Dynamics of changes in the total score of the quality of life questionnaire up to 12 months since enrollment Satisfaction of patients with CGD with combination therapy of COCs and BDD up to 12 months since enrollment Viral load during adjuvant CGD therapy at 6 and 12 months among study participants taking and not taking COC and BDD at 6 and 12 months Adherence to COC and BDD therapy against the background of adjuvant CGD therapy among study participants taking and not taking COCs and BDD up to 12 months since enrollment Normalization of ALT levels during adjuvant CGD therapy at 6 months among study participants taking and not taking COCs AND BDD at 6 months Dynamics of the level of fibrosis during adjuvant CGD therapy at 6 and 12 months among study participants taking and not taking COCs AND BDD at 6 and 12 months Incidence of adverse and serious unexpected adverse reactions associated with the use of COC and BDD up to 12 months since enrollment
Trial Locations
- Locations (7)
State-owned public enterprise with the right of economic management "Enbekshikazakh Interdistrict Multidisciplinary Hospital"
🇰🇿Esik, Almaty Region, Kazakhstan
Karasai interdistrict multidisciplinary hospital
🇰🇿Kaskelen, Almaty Region, Kazakhstan
Hepatology center on the basis of the State Public Enterprise at the RV "City Clinic No. 5"
🇰🇿Almaty, Kazakhstan
State-owned public enterprise with the right of economic management Regional infectious hospital of the state institution "Healthcare Department of the Almaty region"
🇰🇿Taldykorgan, Zhetisu Region, Kazakhstan
Medical Center "iClinic"
🇰🇿Astana, Kazakhstan
LLP "InkarMed"
🇰🇿Aktobe, Kazakhstan
State-owned public enterprise with the right of economic management "Regional Clinical Hospital" of the Department of Public Health of the Turkestan region
🇰🇿Turkestan, Kazakhstan