Granulocyte colony-stimulating factor (G-CSF) and liver regeneration in patients with alcoholic steatohepatitis
Not Applicable
Completed
- Conditions
- Alcoholic steatohepatitisNutritional, Metabolic, Endocrinealcoholic steatohepatitis
- Registration Number
- ISRCTN86571875
- Lead Sponsor
- Foundation for Liver and Gut Studies (FLAGS) (Switzerland)
- Brief Summary
2008 results in https://pubmed.ncbi.nlm.nih.gov/18537187/ (added 30/12/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
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
1. Platelet count <20 g/L
2. International Normalised Ratio (INR) >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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ability of G-CSF to increase circulating CD34 + cells (see Interventions for timepoints of assessment)
- Secondary Outcome Measures
Name Time Method <br> 1. Safety of filgrastim in patients with liver failure<br> 2. Effects of filgrastim on liver regeneration assessed using biological markers and immunohistochemistry<br> 3. Possible influence of filgrastim on liver function<br><br> See Interventions for details of assessments<br>