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

Kazakh Association of Internal Medicine Specialists

Status

Withdrawn

Conditions

Chronic Viral Hepatitis B With Delta-Agent

Study type

Observational

Funder types

Other

Identifiers

NCT06068140

KAIMS-02

Details and patient eligibility

About

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

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.