Liver Cirrhosis Clinical Trial
Official title:
Randomized Trial, Masked, and Placebo Controlled to Assess the Effects of Sapropterin on Hepatic and Systemic Hemodynamics in Patients With Liver Cirrhosis and Portal Hypertension
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. Sapropterin or placebo will be given for two weeks in patients with liver cirrhosis and clinically significant portal hypertension. Systemic and hepatic hemodynamics studies will be performed at baseline and after the intervention to assess the effect of sapropterin.
Status | Completed |
Enrollment | 42 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clínic de Barcelona | Barcelona | |
Spain | Hospital Ramón y Cajal | Madrid | Madrid Community |
Lead Sponsor | Collaborator |
---|---|
Fundacion Clinic per a la Recerca Biomédica |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Hepatic Venous Pressure Gradient | Changes in portal pressure gradient as measured by hepatic vein catheterization, induced by 2 week treatment with sapropterin/placebo | 2 weeks | No |
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