Portal Hypertension
Conditions
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.
Interventions
DRUGPlacebo
Matching placebo capsules for oral administration
DRUGCobiprostone
Cobiprostone capsules for oral administration
Sponsors
Sucampo Pharmaceuticals, Inc.
Sucampo Pharma Americas, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) After Four (4) Weeks of Treatment | 4 weeks |
Countries
United States
Participant flow
Pre-assignment details
9 participants were recruited, but the study terminated before data were collected
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo: 0 mcg capsules three times daily (TID) | 0 |
| 12 mcg TID Cobiprostone 36 mcg
Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID) | 0 |
| 18 mcg TID Cobiprostone 54 mcg
Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID) | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) After Four (4) Weeks of Treatment
Time frame: 4 weeks
Population: Study terminated early, data were not collected.