Alcoholic steatohepatitis Nutritional, Metabolic, Endocrine alcoholic steatohepatitis
Conditions
Interventions
Thirteen patients were randomized to standard care + G-CSF, and 11 patients to standard care only. The random allocation of participants to the two arms of the study were carried out using the sealed
Sponsors
Foundation for Liver and Gut Studies (FLAGS) (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-70 years 2. Recent heavy alcohol intake (>80 g/day) 3. Biopsy-proven alcoholic steatohepatitis 4. Maddrey's score >20 and <70 5. Leucocyte count <15 g/L 6. Ability to give an informed consent
Exclusion criteria
Exclusion criteria: 1. Platelet count 1.9 3. Known hypersensitivity to filgrastim (G-CSF) 4. Creatinine >150 µmol/L 5. Recent (10 days) infection or gastrointestinal hemorrhage 5. Documented hepatocellular carcinoma, hepatitis B, C, or HIV seropositivity 6. Ongoing pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ability of G-CSF to increase circulating CD34 + cells (see Interventions for timepoints of assessment) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety of filgrastim in patients with liver failure 2. Effects of filgrastim on liver regeneration assessed using biological markers and immunohistochemistry 3. Possible influence of filgrastim on liver function See Interventions for details of assessments | — |
Countries
Switzerland
Outcome results
None listed