Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension

Study Overview
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Brief Summary
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The primary purpose of this study is to determine the efficacy and safety of cobiprostone (at two dose levels) as compared to placebo for lowering portal hypertension.

Official Title
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A Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension

Conditions
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Portal Hypertension

Intervention / Treatment
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* Drug: Placebo
* Drug: Cobiprostone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo TID<br>Participants receive matching placebo capsules three times daily (TID) | Drug: Placebo<br>* Matching placebo capsules for oral administration<br>* Other names: Matching placebo;|
| Experimental: 12 mcg TID<br>Participants receive 12 mcg Cobiprostone TID | Drug: Cobiprostone<br>* Cobiprostone capsules for oral administration<br>* Other names: Experimental product;|
| Experimental: 18 mcg TID<br>Participants receive 18 mcg Cobiprostone TID | Drug: Cobiprostone<br>* Cobiprostone capsules for oral administration<br>* Other names: Experimental product;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) After Four (4) Weeks of Treatment |  | 4 weeks |