Extension Study of Carvedilol RCT Study
1 other identifier
interventional
240
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 8, 2021
CompletedFirst Submitted
Initial submission to the registry
April 18, 2021
CompletedFirst Posted
Study publicly available on registry
August 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2024
CompletedAugust 25, 2021
May 1, 2021
3.8 years
April 18, 2021
August 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The progression incidence of esophageal varices after 4-year therapy
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 Outcomes (5)
The incidence of liver cirrhosis decompensation
4-year
The incidence of hepatic cellular carcinoma, death or liver transplantation.
4-year
The change of non-invasive assessment score reflecting liver fibrosis.
4-year
The change of non-invasive assessment score reflecting liver function.
4-year
The dynamic change of liver stiffness quantified by transient elastography.
4-year
Study Arms (2)
Carvedilol+ NUCs therapy
EXPERIMENTALPatients 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.
NUCs therapy
NO INTERVENTIONContinuing 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).
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality, 100015, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Affiliated Hospital of Yanbian University
Yanji, Jilin, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
The First Affiliated Hospital of Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 201620, China
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
Tianjin Second People's Hospital
Tianjin, Tianjin Municipality, China
Tianjin Third Central Hospital, Tianjin Medical University
Tianjin, Tianjin Municipality, China
Tianjin Xiqing Hospital
Tianjin, Tianjin Municipality, China
Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital
Xinjiang, Xinjiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaojuan Ou
Beijing Friendship Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Beijing Friendship Hospital
Study Record Dates
First Submitted
April 18, 2021
First Posted
August 25, 2021
Study Start
January 8, 2021
Primary Completion
October 30, 2024
Study Completion
October 30, 2024
Last Updated
August 25, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share