drugset / Trial / NCT01456286

Randomized Controlled Trial to Assess the Effects of Sapropterin on Hepatic and Systemic Hemodynamics in Patients With Liver Cirrhosis and Portal Hypertension

NCT01456286

Phase 2/3 Completed 42 enrolled Fundacion Clinic per a la Recerca Biomédica
RandomizedParallel-groupSingle-blindTreatment

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. 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.

Timeline

Start
2011-10
Primary completion
2013-10
Completion
2013-10

Drugs

EvaluationDrugModalityDoseRoute
Subject sapropterin Unknown 10 mg/kg Oral