Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension

Inclusion Criteria:

- Patient is >= 18 years of age.

- Patient has clinical and/or pathological diagnosis of intra-hepatic portal
hypertension.

- Patient has clinical diagnosis of cirrhosis.

- Patient has undergone variceal banding.

Exclusion Criteria:

- Patient has a Child-Pugh score >12.

- Patient has portal hypertension resulting from hepatic vein obstruction, portal vein
occlusion, schistosomiasis, portal vein thrombosis, splenic vein thrombosis, or
Budd-Chiari syndrome.

- Variceal banding procedure was performed within 1 month of the screening visit.

- Patient has active or recurrent variceal bleeding, or has had variceal bleeding
within the 12 weeks prior to screening.

- Patient is unwilling to discontinue use of vasoactive drugs from the screening visit
through the end of the study.

- Patient has hepatocellular carcinoma that is being medically treated or is advanced.

- Patient has impaired renal function (i.e., serum creatinine concentration >1.8 mg/dl)

- Patient has a history of liver transplant, or is expected to receive a liver
transplant during the study period.

- Patient has undergone a gastrointestinal or abdominal surgical procedure within 90
days prior to the Screening Visit, or has had a bowel resection at any time.