Description:

Randomized Controlled Trial to Assess the Effects of Sapropterin on Hepatic and Systemic Hemodynamics in Patients With Liver Cirrhosis and Portal Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT01456286

Link:

https://clinicaltrials.gov/show/NCT01456286

Keywords:
Versions (1) ▾
  1. 6/30/20
Copyright Holder:
See clinicaltrials.gov
Uploaded on:

June 30, 2020

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License:
Creative Commons BY 4.0
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Eligibility Liver Cirrhosis NCT01456286

Eligibility Liver Cirrhosis NCT01456286

Inclusion Criteria
liver cirrhosis of any etiology diagnosed by biopsy or by clinical-imaging data
male or female patients between 18-75 years old in whom hepatic vein catheterization is indicated.
clinically significant portal hypertension defined by a hvpg ≥ 10 mmhg.
signed informed consent.
Exclusion Criteria
end-stage liver failure defined by one of the following: prothrombin activity < 40% and/or bilirubin > 5 mg/dl.
pregnancy or breastfeeding.
concomitant beginning of non-selective beta-blockers (propranolol, nadolol) during the administration of sapropterin. beta-blockers are not exclusion criteria if they are on stable doses in the previous 6 weeks.
treatment with carvedilol or nitrates.
previous tips or derivative shunt.
hepatocellular carcinoma exceeding milan criteria.
spontaneous bacterial peritonitis or any active infection when entering in the study.
portal vein thrombosis or cavernomatosis at ultrasound.
chronic heart failure, respiratory failure or chronic renal failure (creatinine >2 mg/dl).
previous convulsions or epilepsy.
hypersensibility to sapropterin or any of its excipients.