Clinical Trial: Efficacy of Granulocyte Colony-stimulating Factor and Erythropoetin for Patients With Acute-on-chronic Liver Failure

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Placebo-controlled Trial to Assess the Efficacy of Granulocyte Colony-stimulating Factor (G-CSF) and Erythropoetin (EPO) in the Survival of Patients With Acute-on-chro

Brief 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


Detailed Summary:

50 patients of ACLF will be enrolled and randomized into G-CSF+EPO or Placebo arms

Baseline investigations:

  • Hematology

    • CBC, Prothrombin time and INR
    • Peripheral smear, Retics

  • Biochemistry

    • Liver function testing, AFP
    • Kidney function test

  • Etiology of acute event:

    • Infectious etiology: IgM anti HAV, IgM anti HEV, IgM anti HBc ( If HBsAg +ve), IgM anti HDV ( If HBsAg +ve), HEV RNA
    • Non Infectious etiology: Alcohol binging in last 4 weeks, hepatotoxic drugs, ANA (>1: 80), IgG , surgeries in past 4 weeks, acute variceal bleed within 4 weeks

  • Etiology of underlying chronic liver disease :

    • Infectious etiology: total antiHBc, anti HCV, HCV RNA, HBV DNA
    • Non infectious etiology: Autoimmune markers, copper studies, iron studies, HOMA IR, FBS Ascitic fluid analysis ( wherever its possible) UGI endoscopy Imaging USG abdomen with Doppler for spleno-portal axis CECT- Triple phase upper abdomen Liver regenerative potential efficacy testing (wherever it is possible) Histology ( by transjugular liver biopsy) Liver Dendritic cells
      Sponsor: Institute of Liver and Biliary Sciences, India

      Current Primary Outcome: Transplant free survival at 3 months. [ Time Frame: 3 months ]

      Original Primary Outcome: Same as current

      Current Secondary Outcome: Transplant free survival at 6 months, histo-pathological evidence of hepatic regeneration and mobilization of CD34/stem cells, improvement in severity assessment indices [ Time Frame: 6 months ]

      Original Secondary Outcome: Same as current

      Information By: Institute of Liver and Biliary Sciences, India

      Dates:
      Date Received: June 26, 2011
      Date Started: July 2011
      Date Completion:
      Last Updated: December 4, 2016
      Last Verified: July 2012