Status:
WITHDRAWN
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
Lead Sponsor:
Kazakh Association of Internal Medicine Specialists
Conditions:
Chronic Viral Hepatitis B With Delta-Agent
Eligibility:
All Genders
18-75 years
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 clinic...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06068140
Start Date
December 1 2023
End Date
June 1 2025
Last Update
July 11 2024
Active Locations (7)
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1
State-owned public enterprise with the right of economic management "Enbekshikazakh Interdistrict Multidisciplinary Hospital"
Esik, Almaty Region, Kazakhstan
2
Karasai interdistrict multidisciplinary hospital
Kaskelen, Almaty Region, Kazakhstan
3
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
4
LLP "InkarMed"
Aktobe, Kazakhstan