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Portal hypertension in cirrhosis
EU CTIS ID: 2023-508535-32-00
What this study is testing
To evaluate the effect of metformin versus placebo during 28 days on HVPG, in patients with cirrhosis and a HVPG ≥ 12 mm Hg already treated with carvedilol. Objectif of the ancillary study : To study the effect of metformin on postprandial changes in systemic haemodynamics and HVPG.
- Therapeutic exploratory (Phase II)
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
- - Age ≥ 18 years
- - 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
- - 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
See the full eligibility criteria
- - Age ≥ 18 years
- - 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
- - 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 months
- - Child-Pugh A or B
- - High likelihood of HVPG ≥ 12 mm Hg based on investigator’s judgement, _confer criteria in the protocole
- - Treatment with carvedilol (≥ 6,25 mg/day) at a stable dose for at least one month
- - 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
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.
Explore other conditions
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.