Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension

Recruitment & Eligibility

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.

Study & Design

Arm && Interventions

Group	Intervention	Description
Placebo TID	Placebo	Participants receive matching placebo capsules three times daily (TID)
18 mcg TID	Cobiprostone	Participants receive 18 mcg Cobiprostone TID
12 mcg TID	Cobiprostone	Participants receive 12 mcg Cobiprostone TID

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) After Four (4) Weeks of Treatment	4 weeks

Secondary Outcome Measures

Name	Time	Method

Recruitment & Eligibility