Extension Study of Carvedilol RCT Study

Liver Cirrhosis Clinical Trial

Official title:

Extension Study of Carvedilol for the Prevention of the Esophageal Varices Progression on HBV Cirrhotic Patients With Anti-Viral Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05021406
• Other study ID #: 2017-P2-104-04
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2021
• Est. completion date: October 30, 2024

Study information

• Verified date: May 2021
• Source: Beijing Friendship Hospital
• Contact: Xiaojuan Ou, Dr
• Phone: +86-010-63138665
• Email: ouxj16[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: October 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension

Intervention

Drug:
• Carvedilol 12.5 MG
Carvedilol is started at a dose of 6.25 mg once per day, and will increase to a dose of 12.5 mg once per day after 1 week. Target dose will be maintained at 12.5 mg once per day if patients with systolic blood pressure not lower than 90 mm Hg and HR no less than 50 beats/min.

Locations

Country	Name	City	State
China	Beijing Ditan Hospital Capital Medical University	Beijing	Beijing
China	Beijing Ditan Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Youan Hospital, Capital Medical University	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	Shanghai Public Health Clinical Center	Shanghai	Shanghai
China	The First Affiliated Hospital of Shanghai Jiao Tong University	Shanghai	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai	Shanghai
China	Tianjin Second People's Hospital	Tianjin	Tianjin
China	Tianjin Third Central Hospital, Tianjin Medical University	Tianjin	Tianjin
China	Tianjin Xiqing Hospital	Tianjin	Tianjin
China	Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital	Xinjiang	Xinjiang
China	Affiliated Hospital of Yanbian University	Yanji	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The progression incidence of esophageal varices after 4-year therapy	Progression of esophageal varices defines as follows: Varices developed from small (F1) to medium or large (F2/F3); Varices developed from medium (F2) to large (F3); New-onset red sign without change in the degree of varices.; Bleeding from esophageal varices.	4-year
Secondary	The incidence of liver cirrhosis decompensation	Cumulative rate of liver cirrhosis decompensation, including bleeding, ascites, hepatic encephalopathy, ect.	4-year
Secondary	The incidence of hepatic cellular carcinoma, death or liver transplantation.	Cumulative rate of hepatic cellular carcinoma, death or liver transplantation.	4-year
Secondary	The change of non-invasive assessment score reflecting liver fibrosis.	Higher scores mean a worse outcome.	4-year
Secondary	The change of non-invasive assessment score reflecting liver function.	Higher scores mean a worse outcome.	4-year
Secondary	The dynamic change of liver stiffness quantified by transient elastography.	The dynamic change of liver stiffness quantified by transient elastography.	4-year