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

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

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).

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of liver and Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Peg GCSF with standard medical therapy	Biological: 20% Albumin; Drug: Peg GCSF; Dietary supplement: Nutrition; Other: Bowel wash; Drug: Terlipressin 1- 4mg,if indicated; Drug: Meropenem or Imepenem, if indicated
ACTIVE_COMPARATOR: Placebo with standard medical therapy	Drug: Placebo; Biological: 20% Albumin; Dietary supplement: Nutrition; Other: Bowel wash; Drug: Terlipressin 1- 4mg,if indicated; Drug: Meropenem or Imepenem, if indicated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Transplant free survival in both groups	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative assessment of CD34 positive cells in serum in both groups.	On Immunohistochemistry of liver biopsy tissue,quantification of + ve CD34 cells will be done	1 year
Quantitative assessment of CD34 positive cells in liver biopsy samples in both groups.	On Immunohistochemistry of liver biopsy tissue,quantification of + ve CD34 cells will be done	1 year
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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2016
• Primary Completion (ACTUAL): July 15, 2017
• Study Completion (ACTUAL): July 15, 2017

Study Registration Dates

• First Submitted: March 22, 2016
• First Submitted That Met QC Criteria: May 26, 2016
• First Posted (ESTIMATE): June 2, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2018
• Last Update Submitted That Met QC Criteria: February 5, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure, Acute; End Stage Liver Disease; Liver Failure; Hepatic Insufficiency; Acute-On-Chronic Liver Failure; Antihypertensive Agents; Anti-Infective Agents; Anti-Bacterial Agents; Vasoconstrictor Agents; Meropenem; Terlipressin
• Other Study ID Numbers: ILBS-ACLF-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO