Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension

• Status: Terminated
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sucampo Pharma Americas, LLC; Sucampo Pharmaceuticals, Inc.
• Collaborator: Sucampo Pharmaceuticals, Inc.

Criteria

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.