Ignite Creation Date:
2024-05-05 @ 11:40 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01383460
Status:
COMPLETED
Last Update Posted:
2016-12-06
First Post:
2011-06-26
Brief Title:
Efficacy of Granulocyte Colony-stimulating Factor and Erythropoetin for Patients With Acute-on-chronic Liver Failure
Sponsor:
Institute of Liver and Biliary Sciences India
Organization:
Institute of Liver and Biliary Sciences India
Study Overview
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-chronic Liver Failure ACLF
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
50 patients of Acute-on-chronic liver failure ACLF will be enrolled and randomized into G-CSFEPO or Placebo arms
Treatment protocol To administer G-CSF in prefilled syringe at a dose of 5 µgkg sc 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 PTINR 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
Treatment protocol To administer G-CSF in prefilled syringe at a dose of 5 µgkg sc 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 PTINR 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 Description:
50 patients of ACLF will be enrolled and randomized into G-CSFEPO 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 CD11c CD40 CD 54 CD 123 BDCA 2 staining by flow cytometry CD 34 cells and CD 133 cells measurement in hepatic venous blood peripheral blood and liver biopsy by flow cytometry Markers of proliferation like ki- 67 proliferating cell nuclear antigen PCNA in hepatic venous blood and liver biopsy Markers of angiogenesis like VEGF v WF in hepatic venous blood Measurement of Hepatic venous pressure gradient HVPG
Treatment protocol To administer G-CSF in prefilled syringe at a dose of 5 µgkg sc 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 PTINR 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
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 CD11c CD40 CD 54 CD 123 BDCA 2 staining by flow cytometry CD 34 cells and CD 133 cells measurement in hepatic venous blood peripheral blood and liver biopsy by flow cytometry Markers of proliferation like ki- 67 proliferating cell nuclear antigen PCNA in hepatic venous blood and liver biopsy Markers of angiogenesis like VEGF v WF in hepatic venous blood Measurement of Hepatic venous pressure gradient HVPG
Treatment protocol To administer G-CSF in prefilled syringe at a dose of 5 µgkg sc 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 PTINR 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None