The Relationship Between Long-term Oral Anti Hepatitis B Nucleoside Analogs and Hepatic Steatosis
A Prospective Observational Study on the Relationship Between Long-term Oral Anti Hepatitis B Nucleoside Analogs and Hepatic Steatosis
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This is a single-center, prospective, observational study involving chronic hepatitis B patients from the Second Affiliated Hospital of Chongqing Medical University.
Research implementation process and route
Recruitment object: Patients with chronic hepatitis B, defined as persistent hepatitis B surface antigen positive for ≥ 6 months, (aged ≥ 18, treatment-naive ) were consecutively recruited for outpatient routine examination between July 2021 and December 2022. We excluded patients with prior history of hepatocellular carcinoma, concomitant hepatitis C virus or human immunodeficiency virus infection, primary biliary cirrhosis, Wilson's disease, autoimmune hepatitis, significant alcohol intake (≥ 30 g per day for male, or ≥ 20 g per day for female), on steatogenic medications, prior liver transplantation. The basic information and various examination indexes of the patients were collected, and the patients were informed that they needed to go to the outpatient clinic of our hospital for follow-up examination every 1 year, with a total follow-up of 3 years.
Data to be collected: general medical history characteristics: medical record number, name, gender, age, , enrollment time, contact information, and name of anti hepatitis B drugs. Examination and inspection indicators: liver function, renal function, blood chart analysis, blood lipid, hepatitis B two half and half, anti hepatitis C virus, anti hepatitis D virus, AIDS syphilis screening, high precision hepatitis B virus-DNA quantification, abdominal color Doppler ultrasound (if necessary CT or MR), transient elastography of the liver.
Follow up: after enrollment, the relevant examination indexes were rechecked every 1 year. The follow-up period was 3 years.
Statistical analysis: after a three-year follow-up, the data collected were tested by t-test and multivariate Cox analysis to analyze whether the long-term use of anti hepatitis B nucleoside (acid) analogues could promote hepatic steatosis.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Chongqing
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Chongqing, Chongqing, Porcelana, 400000
- The Second Affiliated Hospital of Chongqing Medical University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Willing and able to sign informed consent.
- Male or female.
- 18 ≤ age≤ 80.
- Clinical diagnosis of chronic hepatitis B.
- Has not received anti HBV treatment.
Exclusion Criteria:
- With prior history of HCC
- Concomitant HCV or HIV
- Primary biliary cholangitis
- Wilson's disease
- Autoimmune hepatitis
- Significant alcohol intake (≥ 30 g per day for male, or ≥ 20 g per day for female)
- Taking steatogenic medications
- Prior liver transplantation
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
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Group 1: treatment with ETV
The patients in this group were composed of patients with chronic hepatitis B who firstly take entecavir for the treatment of chronic hepatitis B. Take Entecavir capsule orally for a long time, once a day, 0.5mg each time. |
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Group 2: treatment with TAF
The patients in this group were composed of patients with chronic hepatitis B who firstly take Tenofovir alafenamide Fumarate for the treatment of chronic hepatitis B. Take Tenofovir alafenamide Fumarate tablets orally for a long time, 25mg once a day. |
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Group 3: treatment with TDF
The patients in this group were composed of patients with chronic hepatitis B who firstly take Tenofovir disoproxil Fumarate for the treatment of chronic hepatitis B. Tenofovir disoproxil fumarate was orally administered for a long time, once a day, 300mg each time. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Abdominal color Doppler ultrasound (if necessary CT or MR)
Periodo de tiempo: once a year up to 3 years
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Patients with fatty liver were evaluated by abdominal color Doppler ultrasound
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once a year up to 3 years
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Liver transient elastography
Periodo de tiempo: once a year up to 3 years
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The CAP value was obtained from the liver transient elastography.
According to the CAP value, steatosis is divided into mild (CAP 248-267 dB / m), moderate (CAP 268-279 dB / m) and severe (≥ 280 dB / m).
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once a year up to 3 years
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Lipid profiles
Periodo de tiempo: once a year up to 3 years
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Lipid profiles, such as total cholesterol (TC), triglycerides(TG), high-density lipoprotein cholesterol(HDL-C), and low-density lipoprotein cholesterol(LDL-C).
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once a year up to 3 years
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Colaboradores e Investigadores
Investigadores
- Investigador principal: Dazhi Zhang, Doctor, The Second Affiliated Hospital of Chongqing Medical University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Zhangdz2021
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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