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New treatment option for Cirrhosis
Official title Effects of Metformin on Hepatic Venous Pressure Gradient in Patients With Cirrhosis and Portal Hypertension
ClinicalTrials.gov ID: NCT06687265
What this study is testing
What is Metformin?
Metformin is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for cirrhosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Portal hypertension (PHT) is defined by an elevated pressure gradient between the portal vein and the hepatic veins ≥ 5 mm Hg, and is the main vector of complications in cirrhosis. When the hepatic venous pressure gradient (HVPG) is ≥ 10 mm Hg, it is considered as a " clinically significant PHT ": ascites and oesophageal varices (EV) may occur.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- \- Age ≥ 18 years
- Written informed consent to participate in the study
- Medical insurance coverage
- For child-bearing aged women, contraception using oestroprogestative, progestative, intrauterine device, or mechanical contraception
- Diagnosis of cirrhosis based on a liver biopsy, or on clinical, biological, endoscopic, and radiological evidence
You likely can't join if
- Serum total bilirubin \> 50 µmol/L
- Prothrombin ratio \< 50 %
- Transaminases \> 5 ULN
- Need for at least one paracentesis for ascites fluid evacuation in the last 6 months
- Expected follow-up \< 3 months
- Known hypersensitivity to the active substance or any of the excipients
See the full eligibility criteria
- \- Age ≥ 18 years
- Written informed consent to participate in the study
- Medical insurance coverage
- For child-bearing aged women, contraception using oestroprogestative, progestative, intrauterine device, or mechanical contraception
- Diagnosis of cirrhosis based on a liver biopsy, or on clinical, biological, endoscopic, and radiological evidence
- Active cause of cirrhosis, or resolution (alcohol cessation, sustained virological response to direct-acting antiviral treatment for HCV, initiation of nucleoside/nucleotide analog treatment for HBV) for at least 6...
- Child-Pugh A or B
- High likelihood of HVPG ≥ 12 mm Hg based on investigator's judgement, or on the following criteria:
- Investigator's judgement
- active cause of cirrhosis and:
- History of clinical ascites
- Or history of variceal bleeding
- Or liver stiffness by VCTE ≥ 35 kPa on carvedilol in the last two years
- or spleen stiffness by VCTE ≥ 55 kPa on carvedilol in the last two years
- or liver surface nodularity ≥ 2,9 in the last two years
- or HVPG \> 16 mm Hg prior to starting NSBB
- or Laennec 4c cirrhosis on histology
- or resolution of the cause of cirrhosis for at least 6 months and:
- history of clinical ascites in the last 6 months
- or history of variceal bleeding in the last 6 months
- or liver stiffness by VCTE ≥ 35 kPa on carvedilol in the last 6 months
- or spleen stiffness by VCTE ≥ 55 kPa on carvedilol in the last 6 months
- or liver surface nodularity ≥ 2,9 in the last 12 months
- or Laennec 4c cirrhosis on histology in the last 12 months
- Treatment with carvedilol (≥ 6,25 mg/day) at a stable dose for at least one month
- Absence of hepatocellular carcinoma outside at least one nodule \> 3 cm in diameter, or more than 3 nodules, on ultrasound, CT-scan or MRI performed during the previous 6 months
- Serum total bilirubin \> 50 µmol/L
- Prothrombin ratio \< 50 %
- Transaminases \> 5 ULN
- Need for at least one paracentesis for ascites fluid evacuation in the last 6 months
- Expected follow-up \< 3 months
- Known hypersensitivity to the active substance or any of the excipients
- History of lactic acidosis, diabetic acidocetosis, or diabetic precoma
- Ongoing condition that may lead to acute kidney injury or hypoxia: dehydration, severe infection, shock, cardiac decompensation, respiratory failure, or myocardial infarction within the past month
- Known hypersensitivity to all the iodin-containing contrast agents
- Known hypersensitivity to lidocaine for local anesthesia
- Known hypersensitivity to beta-lactam antibiotics if the patient has a history of valve replacement
- Alcohol consumption \> 14 units/week for women or \> 21 units/week for men, current or abstinent for less than 6 months
- Biliary cirrhosis
- Hepatocellular carcinoma with at least one nodule \> 3 cm in diameter, or more than 3 nodules
- Cholangiocarcinoma
- Extra-hepatic cancer without remission
- Severe chronic kidney disease defined as estimated glomerular filtration rate \< 30 mL/min/1,73m2 using the MDRD-6 formula
- Ongoing treatment with metformin, or discontinued for less than 3 months
- Treatment with statins started or discontinued for less than 3 months
- Treatment with nucleoside/nucleotide analogue for HBV, or direct-acting antiviral treatment for HCV, started for less than 6 months
- Complete portal vein thrombosis (main portal trunk, or right branch), or portal cavernoma
- History of TIPS (transjugular intrahepatic portosystemic shunt) / surgical portosystemic derivation / liver transplantation / major hepatectomy
- Ongoing participation in another treatment therapeutic trial
- Pregnant or breastfeeding women
- Patients unable to give consent (under guardianship or curatorship)
- Non-randomisation criteria: HVPG \< 12 mm Hg at the catheterism performed during the first follow-up visit
The study team makes the final eligibility decision.
Where it's taking place
- Clichy, France, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clichy, France, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.