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

NCT06068140 | Withdrawn

• 1 other identifier: KAIMS-02
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 7

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

Conditions

Chronic Viral Hepatitis B With Delta-Agent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kazakh Association of Internal Medicine Specialists: lead

Study Sites (7)

State-owned public enterprise with the right of economic management "Enbekshikazakh Interdistrict Multidisciplinary Hospital"

Esik, Almaty Region, Kazakhstan

Location

Karasai interdistrict multidisciplinary hospital

Kaskelen, Almaty Region, Kazakhstan

Location

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

Location

LLP "InkarMed"

Aktobe, Kazakhstan

Location

Hepatology center on the basis of the State Public Enterprise at the RV "City Clinic No. 5"

Almaty, Kazakhstan

Location

Medical Center "iClinic"

Astana, Kazakhstan

Location

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

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 5, 2023
• Study Start: December 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 11, 2024

Record last verified: 2023-09

Locations

KA (7)