Clinical Trial: Sorafenib for Hepatopulmonary Syndrome

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Sorafenib in Patients With Hepatopulmonary Syndrome: A Double-Blind Randomized Clinical Trial

Brief Summary: The main purpose of this clinical trial is to determine the safety and effects of the study drug, sorafenib, in adults diagnosed with hepatopulmonary syndrome (HPS). The study will evaluate how well the drug is tolerated and its effect on the level of oxygen in the blood and the function of the lung vessels.

Detailed Summary:
Sponsor: University of Pennsylvania

Current Primary Outcome: Difference in changes in alveolar-arterial oxygen gradient between sorafenib and placebo groups [ Time Frame: 12 weeks ]

Original Primary Outcome: Difference in changes in AaPO2 between sorafenib and placebo groups [ Time Frame: 12 weeks ]

measured by Arterial Blood Gas testing


Current Secondary Outcome:

  • Difference in changes in intrapulmonary shunting between sorafenib and placebo groups [ Time Frame: 12 weeks ]
  • Difference in changes in hematopoietic progenitor cells and other biomarker levels between sorafenib and placebo groups [ Time Frame: 8 weeks ]
  • Difference in changes in hematopoietic progenitor cells and other biomarker levels between sorafenib and placebo groups [ Time Frame: 12 weeks ]


Original Secondary Outcome:

  • Difference in changes in intrapulmonary shunting between sorafenib and placebo groups [ Time Frame: 12 weeks ]
  • Difference in changes in HPC and other biomarker levels between sorafenib and placebo groups [ Time Frame: 6 weeks ]
  • Difference in changes in HPC and other biomarker levels between sorafenib and placebo groups [ Time Frame: 12 weeks ]


Information By: University of Pennsylvania

Dates:
Date Received: December 20, 2013
Date Started: March 2014
Date Completion: June 2017
Last Updated: July 5, 2016
Last Verified: July 2016