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Cirrhosis, LiverCarvedilolNCT03736265

Carvedilol for Prevention of Esophageal Varices Progression

A study testing Carvedilol in people with Cirrhosis, Liver and Portal Hypertension, run by Beijing Friendship Hospital at 6 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Carvedilol has been shown to be more potent in decreasing portal hypertension to propranolol. But the efficacy of carvedilol to delay the growth of esophageal varices in chronic hepatitis B patients was unclear. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Cirrhosis, Liver, Portal Hypertension
What is being tested?
Carvedilol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
6 sitesChina
Study dates
9 Oct 2017to 30 Dec 2022
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or Female;
  • HBV-related liver cirrhotic patients with at least two years of antiviral therapy;
  • The presence of small or medium esophageal varices without red color sign;
  • HBV-DNA<1×10E3 IU/ml
  • Signature of informed consent

Who cannot join

  • Previous presence of decompensated cirrhosis including ascites, bleeding and HE (hepatic encephalopathy);
  • Any contra-indications to beta-blockers including asthma, chronic obstructive pulmonary disease, allergic rhinitis, NYHA (New York Heart Association) class IV heart failure, atrioventricular block, sinus bradycardia (HR < 50 bpm), cardiogenic shock, hypotension (SBP < 90 mmHg), sick sinus syndrome, insulin dependent diabetes, peripheral vascular disease.
  • Allergic to Carvedilol;
  • Any malignancy that affects survival；
  • Renal dysfunction；
  • History of beta-blockers within last 3 months；
Show all 9Show fewer
  • History of surgery for portal hypertension；History of prior EVL (endoscopic variceal ligation) or sclerotherapy, history of surgery for portal hypertension including portosystemic shunts, disconnection and spleen resection and transjugular intrahepatic portosystemic shunt；
  • Severe systemic diseases；
  • Refusal to participate in the study.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Beijing Ditan Hospital Capital Medical University

    Beijing, Beijing Municipality, 100015

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Beijing Friendship Hospital

    Beijing, Beijing Municipality, 100050

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200032

  • The First Affiliated Hospital of Shanghai Jiao Tong University

    Shanghai, Shanghai Municipality, 201620

Other trials in China

About this study

Official title: Clinical Study of Carvedilol for the Prevention of the Progression of Esophageal Varices in Hepatitis B Related Cirrhotic Patients With Anti-Viral Therapy

Carvedilol has been shown to be more potent in decreasing portal hypertension to propranolol. But the efficacy of carvedilol to delay the growth of esophageal varices in chronic hepatitis B patients was unclear.

Read the detailed description

It has been concluded 40%-70% of chronic hepatitis B patients can achieve fibrosis/ cirrhosis reversion after effective anti-viral therapy. But there is still some patients progress to decompensation. Esophageal varices are the main complication of cirrhotic patients. Propranolol are widely used to prevent variceal bleeding in patients with large esophageal varices. It has been shown the efficacy of propranolol in the preventing of the progression from small to large varices reported no effect. Recently, carvedilol has been shown to be more potent in decreasing portal hypertension to propranolol. But the efficacy of carvedilol to delay the growth of esophageal varices in chronic hepatitis B patients was unclear. The purpose of this study is to demonstrate the efficacy of carvedilol in the preventing of the progression from small to large varices in hepatitis B patients.

Being tested
Carvedilol
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.

  • CarvedilolDrug

    Also called Nucleos(t)ide Analogues

    Carvedilol is started at a dose of 6.25 mg once daily. After 1 week, this will increased to a dose of 12.5 mg once daily. Target dose of 12.5 mg once daily will be maintained if systolic blood pressure does not fall below 90 mm Hg and HR 50 beats per minute.

Study groups in NCT03736265
Study groupRoleWhat they receive
Carvedilol+ Nucleos(t)ide AnaloguesExperimentalBased on nucleoside analogue (NUCs), carvedilol will added to the patients. Carvedilol is started at a dose of 6.25 mg once daily. After 1 week, this will increased to a dose of 12.5 mg once daily. Target dose of 12.5 mg once daily will be maintained if systolic blood pressure does not fall below 90 mm Hg and HR 50 beats per minute.
Receives: Drug: Carvedilol
Nucleos(t)ide AnaloguesNo interventionContinuing take 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.

  1. The progression Incidence of esophageal varices.

    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. Bleeding from esophageal varices.

    Measured: 2 years

Secondary outcomes (5)

  1. The incidence of liver cirrhosis decompensation

    Cumulative rate of liver decompensation (including ascites,hepatic encephalopathy) after 2 year.

    Measured: 2 years

  2. The incidence of hepatic cellular carcinoma, death or liver transplantation.

    Cumulative rate of hepatic cellular carcinoma, death or liver transplantation after 2 year.

    Measured: 2 years

  3. The progression rate of non-invasive scores (Child-Pugh、MELD、APRI、FIB-4 score).

    The progression rate of Child-Pugh、MELD、APRI、FIB-4 score after 2 years.

    Measured: 2 years

  4. The dynamic change of liver stiffness quantified by transient elastography.

    The dynamic change of liver stiffness quantified by transient elastography after 2 years.

    Measured: 2 years

  5. The dynamic change of hemodynamics parameter

    The dynamic change of hemodynamics (HR and mean arterial pressure) after 2 years.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2018
  2. Study start9 Oct 2017
  3. Primary completion30 Nov 2022 (estimated)
  4. Study completion30 Dec 2022 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
Single blind
Who is masked
Participant
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03736265
Sponsor's protocol ID
2017ZX10203202003
Acronym
Carvedilol
Status last verified
Aug 2022
First submitted
3 May 2018
Last updated
1 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Wang B, Zhou J, Wu X, Sun Y, Li L, Li P, Li M, Jiang W, Xu M, Feng B, Xu X, Cheng J, Xie W, Han T, Wang X, Li H, Piao H, Zhao X, Chen S, Meng T, Guan Q, Meng F, Kong Y, Ou X, Jia J, You H. Carvedilol Plus NUC for Patients With HBV-Compensated Cirrhosis Under Virological Suppression: A Randomized Open-Label Trial. Am J Gastroenterol. 2024 Apr 1;119(4):700-711. doi: 10.14309/ajg.0000000000002569. Epub 2023 Nov 6.

    PubMed 37929952

Questions about this trial

What is this clinical trial studying?

A study testing Carvedilol in people with Cirrhosis, Liver and Portal Hypertension, run by Beijing Friendship Hospital at 6 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 5 inclusion and 9 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 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The progression Incidence of esophageal varices. (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03736265, which also lists 1 linked publication.

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 1 Dec 2022.

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