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

Sucampo Pharma Americas, LLC1 site in 1 country9 target enrollmentJuly 2008

ConditionsPortal Hypertension

InterventionsPlacebo Cobiprostone

DrugsPlacebo Cobiprostone

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Portal Hypertension
Sponsor: Sucampo Pharma Americas, LLC
Enrollment: 9
Locations: 1
Primary Endpoint: Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) After Four (4) Weeks of Treatment
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 2008

End Date

March 2009

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sucampo Pharma Americas, LLC

Responsible Party

Sponsor

Eligibility 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 \>
•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.