Extension Study of Carvedilol RCT Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-08

Study Completion Date

2024-10-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Liver Cirrhosis Portal Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Carvedilol+ NUCs therapy

Patients randomized to Carvedilol combined with NUCs group during the previous 2-year treatment of RCT study; Patients showed the progression of esophageal varices in NUCs group during the 2-year treatment of RCT study. Based on nucleoside analogue (NUCs), carvedilol will be added to the patients. 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.

Group Type EXPERIMENTAL

Carvedilol 12.5 MG

Intervention Type DRUG

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.

NUCs therapy

Continuing take single or combined nucleoside analogue (NUCs) including lamivudine (LAM), adefovir dipivoxil (ADV), entecavir (ETV), telbivudine (TBV), tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Nucleos(t)ide Analogues

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Xiaojuan Ou

Beijing Friendship Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaojuan Ou

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Locations

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