A pilot study to evaluate the safety, tolerability and efficacy of obeticholic acid (INT-747) for the treatment of portal hypertension

Intercept Pharmaceuticals Inc0 sites34 target enrollmentJuly 15, 2011

Overview

No summary available.

Registry

who.int

Start Date

July 15, 2011

End Date

December 31, 2012

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Sponsor

•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 early decompensated cirrhosis (Child\-Pugh score \=7 to \=12\)
•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\. Female patients must be postmenopausal, surgically sterile, or if premenopausal, must be prepared to use at least one 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 one effective method of contraception with all sexual partners unless they have had a prior vasectomy. Effective methods of contraception are considered to be:
•6\.1\. Condom (male or female)
•6\.2\. Diaphragm, with spermicide
•6\.3\. Hormonal (e.g. contraceptive pill, patch, intramuscular implant or injection)
•6\.4\. Intrauterine device (IUD)

•1\. Patients with co\-existing disease including:
•1\.1\. Significant organ failure defined as:
•1\.2\. Respiratory: PaO2 \< 8kPa
•1\.3\. Renal: serum creatinine \>150 µmol/L
•1\.4\. Cardiovascular: haemodynamic requirement for inotropic support
•1\.5\. Central nervous system (CNS): hepatic encephalopathy West Haven Criteria score \>2
•1\.6\. Decompensated cirrhosis with requirement for organ support
•1\.7\. Concomitant hepatobiliary disease (except hepatitis B or C viral disease), e.g., gallstones, primary sclerosing cholangitis, primary biliary cirrhosis
•1\.8\. Known or suspected hepatic or extra hepatic malignancy, unless adequately treated or in complete remission for \= 3 years
•1\.9\. Concomitant pancreatitis