Serelaxin in compensated cirrhosis and portal hypertension patients

• Research type

  Research Study

• Full title

  An exploratory study to investigate the haemodynamic effects of Serelaxin in patients with compensated cirrhosis and portal hypertension

• IRAS ID

  110734

• Contact name

  Jonathan Fallowfield

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2012-000236-26

• Research summary

  Cirrhosis is a consequence of chronic liver disease leading to loss of liver function. Portal hypertension/PHT (characterised by high blood pressure in the portal vein which supplies the liver and other circulatory problems) frequently occurs in cirrhosis and accounts for most of the serious complications of the disease. This study aims to look at the effects of Serelaxin on the liver and kidney blood flow and circulation in patients with cirhosis due to alcohol and high blood pressure in the portal vein. The Study is open-label design involving two parts (A1 & A2 and part B) that will be run in parallel. Approximately 40 patients will be recruited to Part A and 10 patients to Part B = approximately 50 patients will therefore be recruited at a single UK centre. Patients will be assigned to either Part A1 and receive Glypressin©/Terlipressin Acetate treatment, or to Part A2 and receive Serelaxin treatment. Part B uses a single group of subjects with Transjugular Intrahepatic Portosystemic Shunt/TIPSS (a tract between the hepatic and portal veins which is kept open by a stent). Part A will investigate with the use of Magnetic Resonance Angiography/MRA scanning technique, whether Serelaxin increases the total renal arterial blood flow in patients with cirrhosis and high blood pressure in the portal vein after at least 120 mins of infusion. Part B will look at, with the use of direct venous pressure measurement, whether Serelaxin reduces the portal vein pressure in patients with cirrhosis, high blood pressure in the portal vein and a Transjugular Intrahepatic Portosystemic Shunt/TIPSS in place after at least 120 min of infusion. Screening visit 1 lasts approximately one week, followed by visit 2 when drug is administered. Visit 3 is the final/follow-up which will take place approximately 4 weeks after visit 2 on day 29.

• REC name

  Scotland A REC

• REC reference

  12/SS/0177

• Date of REC Opinion

  2 Nov 2012

• REC opinion

  Further Information Favourable Opinion