Extension Study of Carvedilol RCT Study

August 19, 2021 updated by: Xiaojuan Ou, Beijing Friendship Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiaojuan Ou, Dr
  • Phone Number: +86-010-63138665
  • Email: ouxj16@126.com

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
          • Xiaoyuan Xu
        • Contact:
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Friendship Hospital, Capital Medical University
        • Contact:
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Youan Hospital, Capital Medical University
        • Contact:
      • Beijing, Beijing, China, 100015
        • Recruiting
        • Beijing Ditan Hospital Capital Medical University
        • Contact:
          • Wen Xie
        • Contact:
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Ditan Hospital, Capital Medical University
        • Contact:
    • Jilin
      • Yanji, Jilin, China
        • Recruiting
        • Affiliated Hospital of Yanbian University
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China
      • Shanghai, Shanghai, China, 200032
      • Shanghai, Shanghai, China, 201620
        • Recruiting
        • The First Affiliated Hospital of Shanghai Jiao Tong University
        • Contact:
          • Mingyi Xu
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • Tianjin Second People's Hospital
        • Contact:
      • Tianjin, Tianjin, China
        • Recruiting
        • Tianjin Third Central Hospital, Tianjin Medical University
      • Tianjin, Tianjin, China
    • Xinjiang
      • Xinjiang, Xinjiang, China
        • Recruiting
        • Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • Nucleos(t)ide Analogues
No Intervention: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The progression incidence of esophageal varices after 4-year therapy
Time Frame: 4-year

Progression of esophageal varices defines as follows:

  1. Varices developed from small (F1) to medium or large (F2/F3)
  2. Varices developed from medium (F2) to large (F3)
  3. New-onset red sign without change in the degree of varices.
  4. Bleeding from esophageal varices.
4-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of liver cirrhosis decompensation
Time Frame: 4-year
Cumulative rate of liver cirrhosis decompensation, including bleeding, ascites, hepatic encephalopathy, ect.
4-year
The incidence of hepatic cellular carcinoma, death or liver transplantation.
Time Frame: 4-year
Cumulative rate of hepatic cellular carcinoma, death or liver transplantation.
4-year
The change of non-invasive assessment score reflecting liver fibrosis.
Time Frame: 4-year
Higher scores mean a worse outcome.
4-year
The change of non-invasive assessment score reflecting liver function.
Time Frame: 4-year
Higher scores mean a worse outcome.
4-year
The dynamic change of liver stiffness quantified by transient elastography.
Time Frame: 4-year
The dynamic change of liver stiffness quantified by transient elastography.
4-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Friendship Hospital

Investigators

  • Principal Investigator: Xiaojuan Ou, Beijing Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2021

Primary Completion (Anticipated)

October 30, 2024

Study Completion (Anticipated)

October 30, 2024

Study Registration Dates

First Submitted

April 18, 2021

First Submitted That Met QC Criteria

August 19, 2021

First Posted (Actual)

August 25, 2021

Study Record Updates

Last Update Posted (Actual)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 19, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-P2-104-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Cirrhosis

Clinical Trials on Carvedilol 12.5 MG

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe