Efficacy of Granulocyte Colony-stimulating Factor and Erythropoetin for Patients With Acute-on-chronic Liver Failure
Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
Summary
50 patients of Acute-on-chronic liver failure (ACLF) will be enrolled and randomized into
G-CSF+EPO or Placebo arms
Treatment protocol To administer G-CSF (in prefilled syringe) at a dose of 5 µg/kg s/c at
days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses), along with
Darbopoetin alpha 100 mcg/ week (in prefilled syringe) for 4 weeks (total 4 doses).
Standard medical therapy included as per requirement lactulose, bowel wash, albumin,
terlipressin, antibiotics (if indicated) will be continued and recorded. Pentoxiphylline in
alcoholic hepatitis and Tenofovir in Hep B reactivation Controls: Standard medical therapy
will be given along with placebo in similar prefilled syringes.
Follow up Physical examination will be done daily, after 1 week and at 4 weeks, at 2 months,
at 3 months and at 6 months CBC on alternate day for 1 week, at end of 1 week and then at end
of 4 weeks , at 2 months, at 3 months and at 6 months
KFT on alternate day for 1 week, at end of 1 week and then at end of 4 weeks, at 2 months, at
3 months and at 6 months LFT along with PT/INR on alternate day for 1 week, at end of 1 week
and then at end of 4 weeks, at 2 months, at 3 months and at 6 months AFP at baseline, after 4
weeks, at 3 months and at 6 months Liver regenerative potential efficacy testing at baseline
and after 4 weeks