Clinical trial NCT06068140: 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
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Viral Hepatitis B With Delta-Agent
Lead sponsor: Kazakh Association of Internal Medicine Specialists
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility criteria: 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.

Primary outcomes:
measure: 1. Normalization of ALT levels during adjuvant CGD therapy at 12 months among study participants taking and not taking COC and BDD
timeFrame: at 12 months
Secondary outcomes:
measure: Normalization of ALT levels during adjuvant CGD therapy at 6 months among study participants taking and not taking COCs AND BDD
timeFrame: at 6 months
measure: 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
timeFrame: at 6 and 12 months
measure: Viral load during adjuvant CGD therapy at 6 and 12 months among study participants taking and not taking COC and BDD
timeFrame: at 6 and 12 months
measure: Adherence to COC and BDD therapy against the background of adjuvant CGD therapy among study participants taking and not taking COCs and BDD
timeFrame: up to 12 months since enrollment
measure: Dynamics of changes in the total score of the quality of life questionnaire
timeFrame: up to 12 months since enrollment
measure: Incidence of adverse and serious unexpected adverse reactions associated with the use of COC and BDD
timeFrame: up to 12 months since enrollment
measure: Satisfaction of patients with CGD with combination therapy of COCs and BDD
timeFrame: up to 12 months since enrollment
Other outcomes:
Locations:
city: Esik
country: Kazakhstan
facility: State-owned public enterprise with the right of economic management "Enbekshikazakh Interdistrict Multidisciplinary Hospital"
state: Almaty Region
city: Kaskelen
country: Kazakhstan
facility: Karasai interdistrict multidisciplinary hospital
state: Almaty Region
city: Taldykorgan
country: Kazakhstan
facility: State-owned public enterprise with the right of economic management Regional infectious hospital of the state institution "Healthcare Department of the Almaty region"
state: Zhetisu Region
city: Aktobe
country: Kazakhstan
facility: LLP "InkarMed"
city: Almaty
country: Kazakhstan
facility: Hepatology center on the basis of the State Public Enterprise at the RV "City Clinic No. 5"
city: Astana
country: Kazakhstan
facility: Medical Center "iClinic"
city: Turkestan
country: Kazakhstan
facility: State-owned public enterprise with the right of economic management "Regional Clinical Hospital" of the Department of Public Health of the Turkestan region
Study officials:
References: