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
| NCT number | NCT06068140 |
| Other study ID # | KAIMS-02 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | December 2023 |
| Est. completion date | June 2025 |
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
| Status | Not yet recruiting |
| Enrollment | 128 |
| Est. completion date | June 2025 |
| Est. primary completion date | June 2025 |
| Accepts healthy volunteers | |
| 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. |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Kazakh Association of Internal Medicine Specialists |
Kazakhstan,
| 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02888106 -
Myrcludex B in Combination With Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients With Chronic Viral Hepatitis B With Delta-agent
|
Phase 2 |