TECA study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Vienna

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

21 Mar 2025 → ongoing

Decision date (initial)

2025-01-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Ludwig Boltzmann Society

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

To evaluate the hepatic venous pressure gradient-lowering effects of telmisartan in patients with 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

Secondary objectives 6

1. To evaluate the rate of hepatic venous pressure gradient response after 12 weeks of telmisartan treatment compared with placebo
2. To evaluate changes in liver stiffness measurement (in kPa) after 12 weeks of telmisartan treatment compared to placebo
3. To evaluate changes in spleen stiffness measurement (in kPa) after 12 weeks of telmisartan treatment compared to placebo
4. To assess safety and tolerability of telmisartan in patients with compensated advanced chronic liver disease
5. To evaluate changes in systemic hemodynamics after 12 weeks of telmisartan treatment compared to placebo
6. To assess health-related quality of life after 12 weeks of telmisartan treatment compared to placebo (SF36v2, CLDQ-D, FSS)

Conditions and MedDRA coding

compensated advanced chronic liver disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patients with compensated advanced chronic liver disease
2. Age ≥18 years and <80 years
3. Child-Pugh stage A or Child-Pugh stage B and model for end-stage liver disease (MELD) ≤15 points at screening
4. Clinically significant portal hypertension (i.e., hepatic venous pressure gradient ≥10 mmHg) based on an adequate hepatic venous pressure gradient tracing
5. Willingness to provide written informed consent and participate in the study

Exclusion criteria 18

1. Age <18 years and ≥80 years
2. Currently decompensated advanced chronic liver disease or history of hepatic decompensation (clinically evident ascites, variceal bleeding, overt hepatic encephalopathy)
3. Child-Pugh stage C or MELD >15 at screening
4. Total bilirubin ≥3 mg/dL or aspartate transaminase/alanine transaminase >5xULN
5. Absence of clinically significant portal hypertension (i.e., hepatic venous pressure gradient <10 mmHg)
6. Cholestatic liver disease (e.g., primary biliary cholangitis, primary sclerosing cholangitis, secondary sclerosing cholangitis)
7. Vascular liver disease
8. Occlusive portal vein thrombosis
9. History of liver transplantation
10. History of transjugular intrahepatic portosystemic shunt
11. Hepatocellular carcinoma
12. Intake of renin inhibitors, angiotensin converting enzyme inhibitors, angiotensin II type 1 receptor blockers, or neprilysin inhibitors
13. Severe hypotension (defined as systolic blood pressure <100 mmHg) at screening
14. Uncontrolled/severe arterial hypertension
15. Alcohol consumption/illicit drug use that is expected to interfere with study procedures
16. Initiation of hepatitis C virus or hepatitis B virus treatment within the last year
17. Allergy or hypersensitivity to telmisartan or contraindications for telmisartan
18. Pregnancy, breastfeeding, or unwillingness to utilize a highly effective means of contraception for the duration of the study in women with childbearing potential

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is defined as the difference between HVPG at W12 and baseline.

Secondary endpoints 3

1. HVPG response after 12 weeks of treatment is defined as an HVPG decrease ≥10%; i.e., HVPG responders).
2. Change in liver stiffness measurement (in kPa) between W12 and baseline
3. Change in spleen stiffness measurement (in kPa) between W12 and baseline)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Vienna

Sponsor organisation

Medical University Of Vienna

Address

Spitalgasse 23, Alsergrund Alsergrund

City

Vienna

Postcode

1090

Country

Austria

Scientific contact point

Organisation

Medical University Of Vienna

Contact name

Division of Gastroenterology and Hepatology

Public contact point

Organisation

Medical University Of Vienna

Contact name

Division of Gastroenterology and Hepatology

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications