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

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

Study Overview

• Status: Withdrawn
• Conditions: Chronic Viral Hepatitis B With Delta-Agent

• Study Type: Observational

Contacts and Locations

Study Locations

• Kazakhstan
  • Aktobe, Kazakhstan
    • LLP "InkarMed"
  • Almaty, Kazakhstan
    • Hepatology center on the basis of the State Public Enterprise at the RV "City Clinic No. 5"
  • Astana, Kazakhstan
    • Medical Center "iClinic"
  • Turkestan, Kazakhstan
    • State-owned public enterprise with the right of economic management "Regional Clinical Hospital" of the Department of Public Health of the Turkestan region
  • Almaty Region
    • Esik, Almaty Region, Kazakhstan
      • State-owned public enterprise with the right of economic management "Enbekshikazakh Interdistrict Multidisciplinary Hospital"
    • Kaskelen, Almaty Region, Kazakhstan
      • Karasai interdistrict multidisciplinary hospital
  • Zhetisu Region
    • Taldykorgan, Zhetisu Region, Kazakhstan
      • State-owned public enterprise with the right of economic management Regional infectious hospital of the state institution "Healthcare Department of the Almaty region"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Persons aged ≥18 to 75 years inclusive with a diagnosis of chronic hepatitis D who are undergoing outpatient monitoring at the place of residence.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Study Cohort; Patients taking Carnitine-Orotate Complex and Biphenyl Dimethyl Dicarboxylate
Control cohort; Patients who do not take Carnitine-Orotate Complex and Biphenyl Dimethyl Dicarboxylate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Kazakh Association of Internal Medicine Specialists

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: October 3, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Chronic Disease; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis D; Hepatitis D, Chronic; Hepatitis B, Chronic
• Other Study ID Numbers: KAIMS-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No