Status:
COMPLETED
Randomized Controlled Trial to Assess the Effects of Sapropterin on Hepatic and Systemic Hemodynamics in Patients With Liver Cirrhosis and Portal Hypertension
Lead Sponsor:
Fundacion Clinic per a la Recerca Biomédica
Conditions:
Liver Cirrhosis
Portal Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine whether sapropterin (an oral analogue of tetrahydrobiopterin) could have a role in the treatment of portal hypertension secondary to liver cirrhosis. Sapropte...
Detailed Description
Portal hypertension and its complications (variceal bleeding, encephalopathy, spontaneous bacterial peritonitis, hepatorenal syndrome) are the main cause of death and liver transplantation in patients...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01456286
Start Date
October 1 2011
End Date
October 1 2013
Last Update
October 7 2013
Active Locations (2)
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1
Hospital Clínic de Barcelona
Barcelona, Barcelona, Spain, 08036
2
Hospital Ramón y Cajal
Madrid, Madrid Community, Spain, 28034