Extension Study of Carvedilol RCT Study

  • STATUS
    Recruiting
  • participants needed
    240
  • sponsor
    Beijing Friendship Hospital
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Updated on 26 August 2021
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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.

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.

Details
Condition Portal hypertension, Liver Disorders, LIVER DISEASE, Cirrhosis, Liver Disease
Age 18years - 100years
Treatment Carvedilol 12.5 MG
Clinical Study IdentifierNCT05021406
SponsorBeijing Friendship Hospital
Last Modified on26 August 2021

Eligibility

 Yes No Not Sure

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
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