STOPAH: STeroids Or Pentoxifylline for Alcoholic Hepatitis version 1

• Research type

  Research Study

• Full title

  STOPAH: STeroids Or Pentoxifylline for Alcoholic Hepatitis

• IRAS ID

  23962

• Contact name

  m thursz

• Sponsor organisation

  Southampton University Hospitals NHS Trust R&D department

• Eudract number

  2009-013897-42

• ISRCTN Number

  ISRCTN88782125

• Research summary

  Alcohol-related liver disease accounts for the majority of alcohol related deaths in the United Kingdom. Alcoholic hepatitis, where the liver is very inflamed, is a serious form of the disease. The death rate from alcoholic hepatitis is particularly high amongst those patients who have severe alcoholic hepatitis - over 30% within the first month after admission to hospital. There is no proven best treatment for severe alcoholic hepatitis. In some hospitals a medicine called prednisolone is used but this practice is not consistent as there is no definitive evidence to show that it has benefit. Another medicine, called pentoxifylline, has been shown in some clinical trials to be effective in patients with severe alcoholic hepatitis. Unfortunately only one clinical trial of pentoxifylline alone and one trial of pentoxifylline in combination with prednisolone have been reported so conclusions about how well these medicines may work are hard to draw. This is a crucial trial to determine the best treatment option for these very sick patients. This is a randomised controlled clinical trial that will determine whether prednisolone or pentoxifylline reduce the number of deaths associated with severe alcoholic hepatitis at 28 days following the start of treatment.

• REC name

  Wales REC 3

• REC reference

  09/MRE09/59

• Date of REC Opinion

  27 Apr 2010

• REC opinion

  Further Information Favourable Opinion