A Multi-center, Placebo-controlled, randomized pilot study of the effect of Sorafenib on Portal Pressure in Patients with Cirrhosis, Significant Portal Hypertension and Hepatocellular Carcinoma Treated with Ablative Therapy and/or Transarterial Chemoembolization

What is the purpose of this trial?

This is a pilot proof-of-concept study that investigates the effect of sorafenib on portal pressure, as determined by the hepatic venous pressure gradient (HVPG), in patients with liver cirrhosis, portal hypertension and unresectable hepatocellular carcinoma (HCC) that has successfully responded to radiofrequency ablation and/or transarterial chemoembolization, and have obtained a complete response.

The primary end-point of the study is the achievement of at least a 10% reduction in HVPG observed from baseline to three months after starting treatment with sorafenib. Secondary end-point is the mean change in HVPG over this period (three months after initiation of sorafenib/placebo) and safety of sorafenib.

The trial is structured as a randomized double blind placebo controlled study. After a three-month period of therapy with sorafenib or placebo (double-blind phase), patients will be given open-label sorafenib for an additional 3-month period (open-label phase).  A total of 44 patients will be randomized (in the initial phase) on a 1:1 ratio to sorafenib or placebo.  Patients will be followed monthly and HCC follow-up will be according to standards of care. The study will be sponsored by Onyx, who will also provide the treatment medication (sorafenib and placebo)

Participation Guidelines

Click here for detailed information about who can participate in this trial.

Sponsor:

Bayer
Onyx Pharmaceuticals

Dates:

August 2011

Last Updated:

Study HIC#:

1002006266

Clinicaltrials.gov ID: Yale8142467