Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension

Sucampo

Status and phase: Terminated; Phase 2

Conditions: Portal Hypertension

Treatments: Drug: Cobiprostone; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00737594

SPH0721

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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9 participants in 3 patient groups, including a placebo group

Placebo TID

Placebo Comparator group

Description:

Participants receive matching placebo capsules three times daily (TID)

Treatment:

Drug: Placebo

12 mcg TID

Experimental group

Description:

Participants receive 12 mcg Cobiprostone TID

Treatment:

Drug: Cobiprostone

18 mcg TID

Experimental group

Description:

Participants receive 18 mcg Cobiprostone TID

Treatment:

Drug: Cobiprostone