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TECA study
EU CTIS ID: 2024-513351-33-00
What this study is testing
To evaluate the hepatic venous pressure gradient-lowering effects of telmisartan in patients with (re-) compensated advanced chronic liver disease and clinically significant portal hypertension after 12 weeks of treatment in comparison to placebo, as measured by hepatic venous pressure gradient decrease
- 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
- Patients with compensated advanced chronic liver disease, including both compensated and re-compensated patients
- Age ≥18 years and <80 years
- Child-Pugh stage A or Child-Pugh stage B and model for end-stage liver disease (MELD) ≤15 points at screening
- Clinically significant portal hypertension (i.e., hepatic venous pressure gradient ≥10 mmHg) based on an adequate hepatic venous pressure gradient tracing
- Willingness to provide written informed consent and participate in the study
You likely can't join if
- Age <18 years and ≥80 years
- History of transjugular intrahepatic portosystemic shunt
- Hepatocellular carcinoma
- Intake of renin inhibitors, angiotensin converting enzyme inhibitors, angiotensin II type 1 receptor blockers, or neprilysin inhibitors
- Severe hypotension (defined as systolic blood pressure <100 mmHg) at screening
- Uncontrolled/severe arterial hypertension
See the full eligibility criteria
- Patients with compensated advanced chronic liver disease, including both compensated and re-compensated patients
- Age ≥18 years and <80 years
- Child-Pugh stage A or Child-Pugh stage B and model for end-stage liver disease (MELD) ≤15 points at screening
- Clinically significant portal hypertension (i.e., hepatic venous pressure gradient ≥10 mmHg) based on an adequate hepatic venous pressure gradient tracing
- Willingness to provide written informed consent and participate in the study
- Age <18 years and ≥80 years
- History of transjugular intrahepatic portosystemic shunt
- Hepatocellular carcinoma
- Intake of renin inhibitors, angiotensin converting enzyme inhibitors, angiotensin II type 1 receptor blockers, or neprilysin inhibitors
- Severe hypotension (defined as systolic blood pressure <100 mmHg) at screening
- Uncontrolled/severe arterial hypertension
- Alcohol consumption/illicit drug use that is expected to interfere with study procedures
- Initiation of hepatitis C virus or hepatitis B virus treatment within the last year
- Allergy or hypersensitivity to telmisartan or contraindications for telmisartan
- Pregnancy, breastfeeding, or unwillingness to utilize a highly effective means of contraception for the duration of the study in women with childbearing potential
- Currently decompensated advanced chronic liver disease or history of hepatic decompensation (clinically evident ascites, variceal bleeding within the last year, overt hepatic encephalopathy)
- Child-Pugh stage C or MELD >15 at screening
- Total bilirubin ≥3 mg/dL or aspartate transaminase/alanine transaminase >5xULN
- Absence of clinically significant portal hypertension (i.e., hepatic venous pressure gradient <10 mmHg)
- Cholestatic liver disease (e.g., primary biliary cholangitis, primary sclerosing cholangitis, secondary sclerosing cholangitis)
- Vascular liver disease
- Occlusive portal vein thrombosis
- History of liver transplantation
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.