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

Not Applicable

Terminated

• Conditions: Acute on Chronic Liver Failure
• Interventions: Drug: Peg GCSF; Biological: 20% Albumin; Dietary Supplement: Nutrition; Other: Bowel wash; Drug: Meropenem or Imepenem, if indicated; Drug: Terlipressin 1- 4mg,if indicated; Drug: Placebo

• Registration Number: NCT02788240
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-22
• Study Start: 2016-05-01
• Study First Submitted QC: 2016-05-26
• Study First Posted: 2016-06-02
• Primary Completion: 2017-07-15
• Study Completion: 2017-07-15
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-05
• Last Update Posted: 2018-02-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo with standard medical therapy	Meropenem or Imepenem, if indicated	-
Peg GCSF with standard medical therapy	Peg GCSF	-
Peg GCSF with standard medical therapy	20% Albumin	-
Peg GCSF with standard medical therapy	Nutrition	-
Peg GCSF with standard medical therapy	Bowel wash	-
Peg GCSF with standard medical therapy	Terlipressin 1- 4mg,if indicated	-
Peg GCSF with standard medical therapy	Meropenem or Imepenem, if indicated	-
Placebo with standard medical therapy	20% Albumin	-
Placebo with standard medical therapy	Nutrition	-
Placebo with standard medical therapy	Bowel wash	-
Placebo with standard medical therapy	Terlipressin 1- 4mg,if indicated	-
Placebo with standard medical therapy	Placebo	-

Primary Outcome Measures

Name	Time	Method
Transplant free survival in both groups	1 year

Secondary Outcome Measures

Name	Time	Method
Quantitative assessment of CD34 positive cells in serum in both groups.	1 year	On Immunohistochemistry of liver biopsy tissue,quantification of + ve CD34 cells will be done
Quantitative assessment of CD34 positive cells in liver biopsy samples in both groups.	1 year	On Immunohistochemistry of liver biopsy tissue,quantification of + ve CD34 cells will be done
Reduction in liver disease severity indices like CTP (Child-Turcotte-Pugh) by more than one point in both groups.	1 year
Reduction in liver disease severity indices like MELD Na ((Model for End Stage liver disease) by more than 2 points in both groups.	1 year
Development of new onset complications such as hepatic encephalopathy in both groups.	1 year
Development of new onset complications such as hepatorenal syndrome in both groups.	1 year
Development of new onset complications such as sepsis in both groups.	1 year
Development of new onset complications such as Hepatocellular carcinoma (HCC).	1 year
Total number of CD34 positive cells in histopathological examination of bone marrow in both groups	1 year
No of adverse events in both groups	1 year
Reduction in HVPG (Hepatic Venous Pressure Gradient) in both groups	1 year
Reduction in HBV DNA level in both groups.	1 year
Number of patients who will restart alcohol abuse during the follow up period in both groups.	1 year

Trial Locations

Locations (1)

Institute of liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India