Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension

This is an interventional treatment trial for Portal Hypertension Read More

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.