Expired Study
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Dallas, Texas 75390


Purpose:

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.


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.


NCT ID:

NCT00737594


Primary Contact:

Principal Investigator
Don Rockey, MD
University of Texas Southwestern Medical Center


Backup Contact:

N/A


Location Contact:

Dallas, Texas 75390
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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