Clinical trial NCT05021406: Extension Study of Carvedilol RCT Study
Official title: Extension Study of Carvedilol for the Prevention of the Esophageal Varices Progression on HBV Cirrhotic Patients With Anti-Viral Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cirrhosis
Portal Hypertension
Keywords: Portal Hypertension
Esophageal Varices
Carvedilol
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients who have completed 2-years treatment in RCT Study of carvedilol will receive another 2-years extension therapy, aiming to investigate the long-term efficacy of carvedilol for the prevention of esophageal varices in treated HBV cirrhotic patients.

Detailed description: Carvedilol has been shown to be more potent in decreasing portal hypertension than propranolol. But the efficacy of carvedilol to prevent esophageal varices progression in nucleoside analogue (NUCs) treatment HBV related cirrhotic patients was unclear. Previous RCT study aimed to explore the effects of carvedilol for the prevention of the esophageal varices progression on HBV cirrhotic patients with anti-viral therapy has been conducted (NCT03736265). Patients who have completed 2-years treatment in RCT Study of carvedilol will receive another 2-years extension therapy, aiming to investigate the long-term efficacy of carvedilol for the prevention of esophageal varices in treated HBV cirrhotic patients. Patients were allocated according to the outcome of EDGs at 2-year during RCT study. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. A third EGDs will be performed at 4-year.

Eligibility criteria: Inclusion Criteria:

* Subjects who completed the 2-year RCT study of carvedilol in HBV cirrhotic patients with anti-viral therapy;
* Subjects who are willing to participate the extension study.

Exclusion Criteria:

* Subjects who refused to receive 2-year EGD examination during the previous RCT study;
* Subjects who could not compliance with the protocol judged by investigators;
* Subjects who are not suitable for the study judged by investigators.

Primary outcomes:
measure: The progression incidence of esophageal varices after 4-year therapy
timeFrame: 4-year
Secondary outcomes:
measure: The incidence of liver cirrhosis decompensation
timeFrame: 4-year
measure: The incidence of hepatic cellular carcinoma, death or liver transplantation.
timeFrame: 4-year
measure: The change of non-invasive assessment score reflecting liver fibrosis.
timeFrame: 4-year
measure: The change of non-invasive assessment score reflecting liver function.
timeFrame: 4-year
measure: The dynamic change of liver stiffness quantified by transient elastography.
timeFrame: 4-year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Ditan Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Youan Hospital, Capital Medical University
state: Beijing
city: Yanji
country: China
facility: Affiliated Hospital of Yanbian University
state: Jilin
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
city: Shanghai
country: China
facility: The First Affiliated Hospital of Shanghai Jiao Tong University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Second People's Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Third Central Hospital, Tianjin Medical University
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Xiqing Hospital
state: Tianjin
city: Xinjiang
country: China
facility: Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital
state: Xinjiang
Study officials:
affiliation: Beijing Friendship Hospital
name: Xiaojuan Ou
role: PRINCIPAL_INVESTIGATOR
References: