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

Study Overview
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Brief Summary
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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

Official Title
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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
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Chronic Viral Hepatitis B With Delta-Agent

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Cohort<br>Patients taking Carnitine-Orotate Complex and Biphenyl Dimethyl Dicarboxylate | |
| Control cohort<br>Patients who do not take Carnitine-Orotate Complex and Biphenyl Dimethyl Dicarboxylate | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Dynamics of changes in the total score of the quality of life questionnaire |  | up to 12 months since enrollment | 
| Incidence of adverse and serious unexpected adverse reactions associated with the use of COC and BDD |  | up to 12 months since enrollment | 
| Satisfaction of patients with CGD with combination therapy of COCs and BDD |  | up to 12 months since enrollment |