Liver CirrhosisNCT05021406
Extension Study of Carvedilol RCT Study
A study testing Carvedilol 12.5 MG in people with Liver Cirrhosis and Portal Hypertension, run by Beijing Friendship Hospital at 14 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis, Portal Hypertension
- What is being tested?
- Carvedilol 12.5 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 14 sitesChina
- Study dates
- 8 Jan 2021to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites, 14 recruiting
- Recruiting
Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality, 100015
Wen Xie
Xiewen6218@163.com
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Xiaoyuan Xu
xiaoyuanxu6@163.com
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Bo Feng, xyfyfb_1@sina.com
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Bingqiong Wang, +86-13031136358, 13031136358@163.com
- Recruiting
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality
Minghui Li, wuhm2000@sina.com
- Recruiting
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality
Lei Li, 13699119545@163.com
- Recruiting
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Wei Jiang
jiang.wei@zs-hospital.sh.cn
- Recruiting
The First Affiliated Hospital of Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 201620
Mingyi Xu
xumingyi@hotmail.com
- Recruiting
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality
Jilin Cheng, chengjilin@shphc.org.cn
- Recruiting
Tianjin Second People's Hospital
Tianjin, Tianjin Municipality
Ping Li, tjlplxg@163.com
- Recruiting
Tianjin Third Central Hospital, Tianjin Medical University
Tianjin, Tianjin Municipality
Tao Han, hantaomd@126.com
- Recruiting
Tianjin Xiqing Hospital
Tianjin, Tianjin Municipality
Hai Li, 15202265600@163.com
- Recruiting
Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital
Xinjiang, Xinjiang
Xiaozhong Wang, wxz125@sina.com
- Recruiting
Affiliated Hospital of Yanbian University
Yanji, Jilin
Hongxin Piao, 15526770394@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Liver Cirrhosis, Portal Hypertension
- Being tested
- Carvedilol 12.5 MG
- Keywords
- Portal Hypertension, Esophageal Varices, Carvedilol
- Medical subject headings
- Liver Cirrhosis, Hypertension, Portal, Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carvedilol 12.5 MGDrug
Also called Nucleos(t)ide Analogues
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.
| Study group | Role | What they receive |
|---|---|---|
| Carvedilol+ NUCs therapy | Experimental | 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. Receives: Drug: Carvedilol 12.5 MG |
| NUCs therapy | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-year
Secondary outcomes (5)
The incidence of liver cirrhosis decompensation
Cumulative rate of liver cirrhosis decompensation, including bleeding, ascites, hepatic encephalopathy, ect.
Measured: 4-year
The incidence of hepatic cellular carcinoma, death or liver transplantation.
Cumulative rate of hepatic cellular carcinoma, death or liver transplantation.
Measured: 4-year
The change of non-invasive assessment score reflecting liver fibrosis.
Higher scores mean a worse outcome.
Measured: 4-year
The change of non-invasive assessment score reflecting liver function.
Higher scores mean a worse outcome.
Measured: 4-year
The dynamic change of liver stiffness quantified by transient elastography.
The dynamic change of liver stiffness quantified by transient elastography.
Measured: 4-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start8 Jan 2021
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojuan Ou, Beijing Friendship Hospital
- Investigators
- Xiaojuan Ou, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021406
- Sponsor's protocol ID
- 2017-P2-104-04
- Status last verified
- May 2021
- First submitted
- 18 Apr 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extension Study of Carvedilol for the Prevention of the Esophageal Varices Progression on HBV Cirrhotic Patients With Anti-Viral Therapy
- ClinicalTrials.gov ID
- NCT05021406
- Acronym / sponsor ID
- 2017-P2-104-04
- Conditions
- Liver Cirrhosis, Portal Hypertension
- Keywords
- Portal Hypertension, Esophageal Varices, Carvedilol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carvedilol+ NUCs therapy | Experimental | Drug: Carvedilol 12.5 MGPatients 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 intervention | –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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carvedilol 12.5 MGAlso: Nucleos(t)ide AnaloguesCarvedilol 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+ NUCs therapy |
Primary outcome
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.
5 secondary outcomes
The incidence of liver cirrhosis decompensation
Time frame: 4-year
The incidence of hepatic cellular carcinoma, death or liver transplantation.
Time frame: 4-year
The change of non-invasive assessment score reflecting liver fibrosis.
Time frame: 4-year
The change of non-invasive assessment score reflecting liver function.
Time frame: 4-year
The dynamic change of liver stiffness quantified by transient elastography.
Time frame: 4-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaojuan Ou principal investigator
Beijing Friendship Hospital
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carvedilol 12.5 MG in people with Liver Cirrhosis and Portal Hypertension, run by Beijing Friendship Hospital at 14 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaojuan Ou, Dr (+86-010-63138665, ouxj16@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The progression incidence of esophageal varices after 4-year therapy (time frame: 4-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.