A Pilot Study to Evaluate the Safety, Tolerability and Efficacy of Obeticholic Acid (INT-747) for the Treatment of Portal Hypertension (PESTO) - PESTO

Intercept Pharmaceuticals Inc0 sites78 target enrollmentAugust 23, 2012

ConditionsPortal Hypertension in Patients with Cirrhosis MedDRA version: 14.1Level: PTClassification code 10036200Term: Portal hypertensionSystem Organ Class: 10019805 - Hepatobiliary disorders Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Portal Hypertension in Patients with Cirrhosis
Sponsor: Intercept Pharmaceuticals Inc
Enrollment: 78
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 23, 2012

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Intercept Pharmaceuticals Inc

Eligibility Criteria

Inclusion Criteria

•1\. Male or female age 18\-70 years.
•2\. History of alcoholic cirrhosis with clinical or radiological and biochemical evidence of cirrhosis.
•3\. Evidence of a feature of portal hypertension (endoscopic, radiological or other).
•4\. Patients recruited into the cohort evaluation of efficacy must have significant portal hypertension defined as an HVPG \= 12 mmHg.
•5\. Patients with large or grade 3 oesophageal varices as identified by endoscopy within 6 months of screening should be in an endoscopic band ligation program at the time of study entry.
•6\. Patients will be understood to be either abstaining from alcohol for at least 6 weeks, or have a stable low alcohol intake (\= 4 units per day) for at least 6 weeks, and commit to stay abstinent or to consume \= 4 units per day for the duration of the study.
•7\. Female patients must be postmenopausal, surgically sterile, or if premenopausal, must be prepared to use at least 1 effective (\=1% failure rate) method of contraception during the course of the study and for 14 days after the end of dosing. Male patients with female partners of child bearing potential must be prepared to use at least 1 effective method of contraception with all sexual partners unless they have had a prior vasectomy. Effective methods of contraception are considered to be:
•Barrier method, i.e., (a) condom (male or female) or (b) diaphragm, with spermicide; orHormonal (e.g., contraceptive pill, patch, intramuscular implant or injection); or
•Intrauterine device (IUD); or
•Vasectomy (partner)

Exclusion Criteria

•Patients will be excluded from the study if they meet any of the following:
•1\. Patients with co\-existing disease including:
•Significant organ failure defined as:
•o Respiratory: PaO2 \< 8kPa
•o Renal: serum creatinine \> 150 µmol/L
•o Cardiovascular: haemodynamic requirement for inotropic support
•o CNS: hepatic encephalopathy West Haven Criteria score \> 2
•Decompensated cirrhosis with a Child\-Pugh score \> 12 or with a requirement for organ support
•Concomitant hepatobiliary disease (except hepatitis B or C viral disease), e.g., primary sclerosing cholangitis, primary biliary cirrhosis
•Known or suspected hepatic or extra hepatic malignancy, unless adequately treated or in complete remission for \= 3 years