Clinical trial to compare the administration of a single dose of two different medicines in patients with hepatic cirrhosis and portal hypertension.

Phase 1

• Conditions: The proposed study aims to investigate the hemodynamic effects of terlipressin and the time profile of these effects in patients with cirrhosis and portal hypertension when given as continuous infusion and compare it with that achieved when given as a bolus. In addition it also aims to evaluate the hemodynamic effects of octreotide in patients with cirrhosis and portal hypertension; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-004328-39-ES
• Lead Sponsor: Fundació Clínic per a la Recerca Biomèdica_FCRB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-28
• Last Update Posted: 11 May 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1.Age 18-75 years old.
2.Liver cirrhosis defined by standard clinical criteria, ultrasonographic findings and/or histology. Cirrhosis of any aetiology may be included.
3.Child-Pugh B patients or Child-Pugh C patients (up to 12 points).
4.Portal hypertension (defined as HVPG =12mmHg, confirmed during hepatic vein catheterisation)
5.Stable disease in the absence of vasoactive agents
6.Signed informed consent form
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

1.Patients on medications that can prolong the QT interval, a prior history of QT prolongation or on any medication with a known risk of QT prolongation and Torsade de Pointes.
2.Morbid obesity
3.Prior history of cardiovascular disease including ischemic heart disease or intestinal ischemia.
4.Plasma sodium <130mmol/l
5.Serum creatinine =2 mg/dL (176.8 µmol/L).
6.Serum bilirubin>5 mg/dL (85.5 µmol/L).
7.INR =2.5.
8.Bacterial infection within 10 days before study inclusion.
9.Gastrointestinal bleeding within 10 days before study inclusion.
10. Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the New-Haven classification.
11.Child-Pugh C patients (= 12 points).
12.Patients with active hepatocellular carcinoma or history of hepatocellular carcinoma that is in remission for less than six months for uninodular HCC or for less than 12 months for multinodular HCC within Milan criteria. (Patients with HCC not fulfilling Milan criteria for liver transplant)
13.HIV infection.
14.Patients with a history of significant extra hepatic disease with impaired short-term prognosis, including congestive heart failure New York Heart Association Grade III/IV, COPD GOLD >2, chronic kidney disease with serum creatinine >2mg/dL or under renal replacement therapy.
15.Patients with current extra hepatic malignancies including solid tumours and hematologic disorders.
16.Pregnancy or breastfeeding.
17.Patients included in other clinical trials in the month before inclusion.
18.Patients with mental incapacity, language barrier, bad social support or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.
19.Refusal to give informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified