Trial Name

STOPHA - STeroids or Pentoxifylline for Alcoholic Hepatitis

Description

STOPAH is a multicentre randomised double-blind factorial (2x2) trial. The planned interventions will be prednisolone (40mg) or pentoxifylline (400mg) in one of four combinations: placebo/placebo, placebo/prednisolone, pentoxifylline/placebo or pentoxifylline/prednisolone in patients with severe alcoholic hepatitis.

Objectives

• Primary Objective - To determine whether corticosteroids or pentoxifylline reduce the mortality associated with severe alcoholic hepatitis, at 28 days.
• Secondary Objective - Mortality at 90 days and 1 year.

Design

The study will be performed using a multicentre, double-blind, factorial (2 x 2) design in which patients will be randomised to one of four groups:

• Group A: placebo / placebo
• Group B: placebo / prednisolone
• Group C: pentoxifylline / placebo
• Group D: pentoxifylline / prednisolone

Status

Complete

Population

1200 patients with severe alcoholic hepatitis.

Publication

The clinical effectiveness and cost-effectiveness of STeroids Or Pentoxifylline for Alcoholic Hepatitis (STOPAH): a 2?×?2 factorial randomised controlled trial

Steroids or pentoxifylline for alcoholic hepatitis (STOPAH): study protocol for a randomised controlled trial

Prednisolone or pentoxifylline for alcoholic hepatitis

Contact Details

All Trial enquiries should be addressed to ctu@soton.ac.uk