Authorised Therapeutic use (Phase IV) Asymptomatic Child-Pugh A5 to B8 cirrhosis

Effect of long-term carvedilol to prevent decompensation or death in patients with asymptomatic Child-Pugh A5 to B8 cirrhosis and clinically significant portal hypertension: a multicenter, double-blind, randomized controlled trial.

Q: Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Q: Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

Q: How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Q: Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

EU CTIS ID: 2024-511663-28-00

What this study is testing

To evaluate the effect of low dose carvedilol (12.5 mg per day) versus placebo on the occurrence of decompensation of cirrhosis or liverrelated death at 36 months in patients with asymptomatic Child-Pugh class A5 to B8 cirrhosis clinically significant portal hypertension (estimated using NITs) without high-risk varices and : - In virus- and/or alcohol-related and non-obese (BMI 55 kPa

Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Male or female≥ 18 years of age
2. Cirrhosis related to hepatitis C or hepatitis B virus without viral replication for at least 2 years. Or Cirrhosis related to alcohol consumption (active or abstinent)
3. - In virus- and/or alcohol-related and non-obese (BMI <30 kg/m2) MASLD-related cirrhosis, either o 2 TE-LSM ≥25 kPa (measured using the M or XL probe), performed in fasting condition, within 12 months before inclusion - Or (in all patients, including obese (BMI ≥30 kg/m2) MASLDrelated cirrhosis) o 2 estimated probability of CSPH ≥75% assessed by ANTICIPATE- NASH or NICER model, with TE-LSM/TESSM performed in fasting condition, within 12 months before inclusion o 2 TE-SSM ≥55 kPa (measured using the 100 Hz probe) performed in fasting condition, within 12 months before inclusion
4. Absence of medium or large varices or small varices with red signs at endoscopy within 3 months before inclusion
5. Child-Pugh A5 to B8
6. Affiliation to a French social security system.

You likely can't join if

1. History of overt ascites or encephalopathy <12 months before inclusion
10. Known hypersensitivity to carvedilol
11. Concomitant use of Cimétidin
12. Concomitant use of class I antiarythmic agents (except lidocaïn) (i.e.cibenzoline, disopyramide, flécaı̈nide, hydroquinidine méxilétine, propafenone, quinidine)
13. Concomitant use of calcium antagonists: diltiazem, vérapamil and bépridil
14. Concomitant use of clonidine, méthyldopa, guanfacine, moxonidine, rilménidine

See the full eligibility criteria

Who can join

1. Male or female≥ 18 years of age
2. Cirrhosis related to hepatitis C or hepatitis B virus without viral replication for at least 2 years. Or Cirrhosis related to alcohol consumption (active or abstinent)
3. - In virus- and/or alcohol-related and non-obese (BMI <30 kg/m2) MASLD-related cirrhosis, either o 2 TE-LSM ≥25 kPa (measured using the M or XL probe), performed in fasting condition, within 12 months before inclusion - Or (in all patients, including obese (BMI ≥30 kg/m2) MASLDrelated cirrhosis) o 2 estimated probability of CSPH ≥75% assessed by ANTICIPATE- NASH or NICER model, with TE-LSM/TESSM performed in fasting condition, within 12 months before inclusion o 2 TE-SSM ≥55 kPa (measured using the 100 Hz probe) performed in fasting condition, within 12 months before inclusion
4. Absence of medium or large varices or small varices with red signs at endoscopy within 3 months before inclusion
5. Child-Pugh A5 to B8
6. Affiliation to a French social security system.
7. Written informed consent obtained from the participant or guardian/ curator
8. For child-bearing aged women, contraception using oral contraceptive, or intrauterine device or mechanical contraception

What rules you out

1. History of overt ascites or encephalopathy <12 months before inclusion
10. Known hypersensitivity to carvedilol
11. Concomitant use of Cimétidin
12. Concomitant use of class I antiarythmic agents (except lidocaïn) (i.e.cibenzoline, disopyramide, flécaı̈nide, hydroquinidine méxilétine, propafenone, quinidine)
13. Concomitant use of calcium antagonists: diltiazem, vérapamil and bépridil
14. Concomitant use of clonidine, méthyldopa, guanfacine, moxonidine, rilménidine
15. Concomitant use of fingolimod
16. Concomitant use of potent inhibitors (e.g. ketoconazole, HIV protease inhibitors) or inductors (e.g. rifampin, carbamazepine, phenytoin) of CYP3A4 (see appendix 7)
17. Pregnancy or breastfeeding
18. Non ability for participant to comply with the requirements of the study
19. Life expectancy <12 months
2. Treatment with either diuretics or lactulose or rifaximin <3 months before inclusion
3. Any history of portal hypertension related bleeding
4. Baseline heart rate <65/min or systolic blood pressure <100 mm Hg
5. Previous transjugular intrahepatic portosystemic shunt (TIPSS) or liver transplantation
6. Previous history or active hepatocellular carcinoma
7. Glomerular filtration rate (CKD-Epi) < 30 mL/min
8. Strict indication to selective or nonselective beta-blockers: history of acute myocardial infarction, congestive heart failure
9. Strict contraindication to selective or nonselective beta-blockers: o decompensated congestive heart failure o grade 2 or 3 atrioventricular block o sinus node dysfunction without pacemaker o severe asthma according to WHO classification [63] o severe Chronic Obstructive Pulmonary Disease, defined stage 3 or 4 of the GOLD classification, i.e.FEV1<50% of the predicted value (https://goldcopd.org/) o severe Raynaud disease, defined as repetitive episodes of biphasic colour (at least two) of pallor, cyanosis, erythema, in addition to paresthesia or numbness, occurring in both cold and normal environments [64].

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.