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

Chronic Viral Hepatitis B With Delta-Agent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06068140
• Other study ID #: KAIMS-02
• Status: Not yet recruiting
• Start date: December 2023
• Est. completion date: June 2025

Study information

• Verified date: September 2023
• Source: Kazakh Association of Internal Medicine Specialists
• Contact: Aigul Dzhumabaeva
• Phone: +77015122326
• Email: almusa010[@]mail.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 128
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Viral Hepatitis B With Delta-Agent
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis D
• Hepatitis D, Chronic

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Kazakh Association of Internal Medicine Specialists

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Normalization of ALT levels during adjuvant CGD therapy at 6 months among study participants taking and not taking COCs AND BDD		at 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Dynamics of changes in the total score of the quality of life questionnaire		up to 12 months since enrollment
Secondary	Incidence of adverse and serious unexpected adverse reactions associated with the use of COC and BDD		up to 12 months since enrollment
Secondary	Satisfaction of patients with CGD with combination therapy of COCs and BDD		up to 12 months since enrollment