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To Study the Influence of GCSF on Natural History of Acute On Chronic Liver Failure After the Acute Phase

I

Institute of Liver and Biliary Sciences, India

Status

Terminated

Conditions

Acute on Chronic Liver Failure

Treatments

Biological: 20% Albumin
Dietary Supplement: Nutrition
Drug: Peg GCSF
Drug: Placebo
Drug: Terlipressin 1- 4mg,if indicated
Other: Bowel wash
Drug: Meropenem or Imepenem, if indicated

Study type

Interventional

Funder types

Other

Identifiers

NCT02788240
ILBS-ACLF-008

Details and patient eligibility

About

All consecutive ACLF (Acute on Chronic Liver failure) patients presenting to the institute of liver and biliary sciences, irrespective of the etiology , who have survived the acute phase (i.e. 90 days of onset of the acute on chronic liver failure) and who are willing to participate in the study would be enrolled. After performing baseline biochemical tests, patients will undergo transjugular liver biopsy (TJLB), HVPG (Hepatic Venous Pressure Gradient), Circulating CD34 cells, Bone marrow aspiration and biopsy (Histopathological and immunohistochemical examination will be done).

Enrollment

14 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects aged 18-65 years
  • All patients who were known to have ACLF and have survived 3 months of the onset of acute event
  • Patients willing to participate in the study

Exclusion criteria

  • Presence of AKI (Acute Kidney Injury)
  • Active sepsis (Blood/ urine culture positive, SBP (Spontaneous bacterial Peritonitis, LRTI (lower Respiratory Tract infection)
  • Sickle cell anemia
  • HepatoCellular Carcinoma
  • Hematological malignancies
  • Multi organ failure
  • Grade 3/ 4 HE (Hepatic Encephalopathy)
  • HIV seropositivity
  • Pregnancy
  • Patients being taken up for transplant
  • Refusal to participate in the study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

14 participants in 2 patient groups

Peg GCSF with standard medical therapy
Experimental group
Treatment:
Drug: Meropenem or Imepenem, if indicated
Drug: Peg GCSF
Biological: 20% Albumin
Dietary Supplement: Nutrition
Other: Bowel wash
Drug: Terlipressin 1- 4mg,if indicated
Placebo with standard medical therapy
Active Comparator group
Treatment:
Drug: Meropenem or Imepenem, if indicated
Biological: 20% Albumin
Dietary Supplement: Nutrition
Drug: Placebo
Other: Bowel wash
Drug: Terlipressin 1- 4mg,if indicated

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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