Efficacy and Safety of Cobiprostone in Patients With Portal Hypertension

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Assess Safety and Efficacy of Ifetroban for Treatment of Portal Hypertension in Cirrhotic Patients

NCT02802228

Portal Hypertension Liver Cirrhosis

COMPLETED PHASE2

Evaluation of Efficacy and Safety of Somatostatin Used as Inflow Modulator in Liver Transplantation.

NCT01290172

Liver Transplant With Clinically Significant Portal Hypertension

COMPLETED PHASE1

Ezetimibe Versus Placebo in the Treatment of Non-alcoholic Steatohepatitis

NCT01766713

Non Alcoholic Steatohepatitis

COMPLETED PHASE2

CS0159 in Chinese Patients With PBC (Primary Biliary Cholangitis)

NCT05896124

Primary Biliary Cholangitis (PBC)

ACTIVE_NOT_RECRUITING PHASE2

Clinical Trial to Evaluation the Safety and Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis and Resultant Portal Hypertension in Patients With Nash Cirrhosis

NCT02462967

Hypertension, Portal

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Portal Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo TID

Participants receive matching placebo capsules three times daily (TID)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo capsules for oral administration

12 mcg TID

Participants receive 12 mcg Cobiprostone TID

Group Type EXPERIMENTAL

Cobiprostone

Intervention Type DRUG

Cobiprostone capsules for oral administration

18 mcg TID

Participants receive 18 mcg Cobiprostone TID

Group Type EXPERIMENTAL

Cobiprostone

Intervention Type DRUG

Cobiprostone capsules for oral administration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

Matching placebo capsules for oral administration

Intervention Type DRUG

Cobiprostone

Cobiprostone capsules for oral administration

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Matching placebo Experimental product

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No