NCT06068140撤回不适用
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
Kazakh Association of Internal Medicine Specialists7 个研究点 分布在 1 个国家开始时间: 2023年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 7
- 主要终点
- 1. Normalization of ALT levels during adjuvant CGD therapy at 12 months among study participants taking and not taking COC and BDD
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
1. Normalization of ALT levels during adjuvant CGD therapy at 12 months among study participants taking and not taking COC and BDD
时间窗: at 12 months
次要结局
- Dynamics of changes in the total score of the quality of life questionnaire(up to 12 months since enrollment)
- Satisfaction of patients with CGD with combination therapy of COCs and BDD(up to 12 months since enrollment)
- 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)
- 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)
- Incidence of adverse and serious unexpected adverse reactions associated with the use of COC and BDD(up to 12 months since enrollment)
研究者
研究点 (7)
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