Sorafenib for Hepatopulmonary Syndrome

Exclusion Criteria

• •Recent chronic heavy alcohol consumption
• •Enrollment in a clinical trial or concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 28 days of screening visit
• •Current hepatic encephalopathy
• •Active infection
• •Diagnosis of portopulmonary hypertension
• •WHO Class IV functional status
• •Congenital long-QT syndrome
• •Subjects who have used strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, phenobarbital, St. John's Wort \[Hypericum perforatum\], dexamethasone at a dose of greater than 16 mg daily, or rifampin \[rifampicin\], and/or rifabutin) within 28 days before randomization
• •Subjects who are currently taking Coumadin®(warfarin)
• •Active or clinically significant cardiac disease, including:
• •1. Active coronary artery disease
• •2. Unstable angina (anginal symptoms at rest), new-onset angina within 12 weeks before randomization, or myocardial infarction within 24 weeks before randomization
• •Liver or other solid organ transplant recipients
• •Expectation of liver transplant within four months of randomization
• •Hepatocellular carcinoma that does not meet all of the following criteria:
• •1. Single lesion ≤ 3 cm documented by LIRADS criteria
• •2. Complete response to ablative therapy (TACE, RFA, alcohol ablation) using the modified RECIST criteria one month after therapy with no more than two treatments
• •3. No other lesions develop after initiation of HCC therapy
• •Uncontrolled hypertension (systolic pressure \>140 mm Hg or diastolic pressure \> 90 mm Hg on repeated measurement) despite optimal medical management.
• •Any hemorrhage/bleeding event of NCI-Common Toxicity Criteria for Adverse Effects v4.0 Grade 3 or higher within 4 weeks before randomization
• •Presence of a non-healing wound, non-healing ulcer, or bone fracture
• •Women who are pregnant or breast-feeding
• •Major surgery 28 days prior to randomization
• •Subjects with any previously untreated or concurrent cancer except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor. Subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before randomization are allowed. All cancer treatments (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) must be completed at least 3 years prior to study entry (i.e., signature date of the informed consent form).
• •Inability to comply with the protocol and/or not willing or not available for follow-up assessments