Inhaled Carbon Monoxide therapy administered over 16 weeks

Hypertension, Pulmonary

150 ppm x 3 hours once weekly (week 1) 150 ppm x 3 hours twice weekly (week 2) 150 ppm x 3 hours three times a week (week 3-16)

Carbon Monoxide

University of Illinois at Chicago Medical Center

Carbon Monoxide Therapy for Severe Pulmonary Arterial Hypertension

Roberto Machado, M.D.

Associate Professor of Pulmonary Medicine

University of Illinois at Chicago

National Institutes of Health (NIH)

National Heart, Lung, and Blood Institute (NHLBI)

Participants randomized to the Control Arm (sorafenib with placebo) receive sorafenib as the standard of care, and placebo for the same periods as participants randomized to the Treatment Arm (sorafenib plus VT-122). Participants randomized to the Control Arm will undergo the same visits and procedures as would the participants randomized to the Treatment Arm.

Participants will be on sorafenib at least 30 days before randomization into either the Treatment or Control Arms. Sorafenib will be administered according to the package insert unless contraindicated based on physician expertise.

Sorafenib

Participants randomized to the VT-122 regimen (sorafenib plus VT-122) will receive oral doses of propranolol and etodolac, which will be titrated over a period of 3 weeks until the participant reaches a maximum tolerated dose (MTD)[no higher than 60 mg propranolol, twice daily (BID)/300 mg etodolac, BID]. Once the individual MTD has been reached, participants will enter a Maintenance Treatment period, and will receive the VT-122 regimen (propranolol and etodolac, co administered orally) on a continuous BID dosing schedule for a maximum of twelve 4-week cycles.

VT-122 (propranolol plus etodolac)

Participants randomized to the Control Arm (sorafenib with placebo) will receive placebo for the same periods as participants randomized to the Treatment Arm. Participants in the Control Arm will undergo the same visits and mock dose escalation.

Placebo

Vicus Clinical Site

Study of Sorafenib With or Without VT-122 in Patients With Hepatocellular Carcinoma (HCC)

A Randomized, Double Blind, Placebo Controlled, Multicenter Phase 2 Study of VT-122 in Combination With Sorafenib Compared to Sorafenib With Placebo in Patients With Hepatocellular Carcinoma and Systemic Inflammation at Risk for Cachexia

oxygenase/fatigue

Carbon Monoxide Therapy for Severe Pulmonary Arterial Hypertension

Study of Sorafenib With or Without VT-122 in Patients With Hepatocellular Carcinoma (HCC)

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