Pilot Study Of Obeticholic Acid In Portal Hypertension

• Research type

  Research Study

• Full title

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

• IRAS ID

  66155

• Contact name

  Rajeshwar Prisad Mookerjee

• Sponsor organisation

  Intercept Pharmaceuticals Inc

• Eudract number

  2010-023241-29

• ISRCTN Number

  isrctn

• Research summary

  Title: What are the effects of obeticholic acid (OCA) on portal hypertension (high blood Pressure in the liver) in patients with the liver disease cirrhosis?Summary: Liver cirrhosismeans that there is scarring in the liver characterestic of advanced liver disease,. This can increase the blood Pressure inside it, a condition known as portal hypertension. This condition is associated with life-threatening several complications , some being life-threatening including bleeding from the gut, kidney damage and brain problems. Lowering the blood Pressure in the liver is expected to reduce such complications.This study is evaluatesing whether the investigational drug obeticholic acid (OCA) has any effects oncan reduce portal hypertension in patients with liver cirrhosis. There are no approved drugs for this condition and those treatments which have shown'some benefit, drugs called beta- blockers (e.g. propranolol), can beare associated with bad side effects. There is therefore a clear medical need for a safe and effective treatment.This new drug OCA has been shown to lower portal blood Pressure in animal studies and this study is designed to see if it has similar effects in patients OCA has also already been'studied in patients with other liver diseases, and been shown to be well tolerated in patients with the chronic liver disease primary biliary cirrhosis (PBC) and in patients with diabetes and fatty liver disease.This study will also assess the side effects of OCA . Up to 39 patients with alcoholic cirrhosis of the liver and portal hypertension will be studied at ain the specialist liver unit at The Royal Free Hospital.All patients will receive the drug OCA for up to 12 days and be evaluated for up to 6 weeks.Different doses will be studied but each a given patient will take the same dose every day during the study.The potential formside effects will be studied in all the patients and 23 patients will also be evaluated to see if OCA has an effect on portal blood Pressure, and liver and kidney function. Intercept Pharmaceuticals are funding the research.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  10/H0709/79

• Date of REC Opinion

  10 Dec 2010

• REC opinion

  Further Information Favourable Opinion