Back to resultsTo Study the Influence of GCSF on Natural History of Acute On Chronic Liver Failure After the Acute Phase
Primary Purpose
Acute on Chronic Liver Failure
Status
Terminated
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Peg GCSF
20% Albumin
Nutrition
Bowel wash
Terlipressin 1- 4mg,if indicated
Meropenem or Imepenem, if indicated
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute on Chronic Liver Failure
Eligibility Criteria
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
Sites / Locations
- Institute of liver and Biliary Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Peg GCSF with standard medical therapy
Placebo with standard medical therapy
Arm Description
Outcomes
Primary Outcome Measures
Transplant free survival in both groups
Secondary Outcome Measures
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
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
Reduction in liver disease severity indices like CTP (Child-Turcotte-Pugh) by more than one point in both groups.
Reduction in liver disease severity indices like MELD Na ((Model for End Stage liver disease) by more than 2 points in both groups.
Development of new onset complications such as hepatic encephalopathy in both groups.
Development of new onset complications such as hepatorenal syndrome in both groups.
Development of new onset complications such as sepsis in both groups.
Development of new onset complications such as Hepatocellular carcinoma (HCC).
Total number of CD34 positive cells in histopathological examination of bone marrow in both groups
No of adverse events in both groups
Reduction in HVPG (Hepatic Venous Pressure Gradient) in both groups
Reduction in HBV DNA level in both groups.
Number of patients who will restart alcohol abuse during the follow up period in both groups.
Full Information
NCT ID
NCT02788240
First Posted
March 22, 2016
Last Updated
February 5, 2018
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT02788240
Brief Title
To Study the Influence of GCSF on Natural History of Acute On Chronic Liver Failure After the Acute Phase
Official Title
To Study the Influence of GCSF on Natural History of Acute On Chronic Liver Failure After the Acute Phase - A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
July 15, 2017 (Actual)
Study Completion Date
July 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute on Chronic Liver Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peg GCSF with standard medical therapy
Arm Type
Experimental
Arm Title
Placebo with standard medical therapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Peg GCSF
Intervention Type
Biological
Intervention Name(s)
20% Albumin
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutrition
Intervention Type
Other
Intervention Name(s)
Bowel wash
Intervention Type
Drug
Intervention Name(s)
Terlipressin 1- 4mg,if indicated
Intervention Type
Drug
Intervention Name(s)
Meropenem or Imepenem, if indicated
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Transplant free survival in both groups
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Quantitative assessment of CD34 positive cells in serum in both groups.
Description
On Immunohistochemistry of liver biopsy tissue,quantification of + ve CD34 cells will be done
Time Frame
1 year
Title
Quantitative assessment of CD34 positive cells in liver biopsy samples in both groups.
Description
On Immunohistochemistry of liver biopsy tissue,quantification of + ve CD34 cells will be done
Time Frame
1 year
Title
Reduction in liver disease severity indices like CTP (Child-Turcotte-Pugh) by more than one point in both groups.
Time Frame
1 year
Title
Reduction in liver disease severity indices like MELD Na ((Model for End Stage liver disease) by more than 2 points in both groups.
Time Frame
1 year
Title
Development of new onset complications such as hepatic encephalopathy in both groups.
Time Frame
1 year
Title
Development of new onset complications such as hepatorenal syndrome in both groups.
Time Frame
1 year
Title
Development of new onset complications such as sepsis in both groups.
Time Frame
1 year
Title
Development of new onset complications such as Hepatocellular carcinoma (HCC).
Time Frame
1 year
Title
Total number of CD34 positive cells in histopathological examination of bone marrow in both groups
Time Frame
1 year
Title
No of adverse events in both groups
Time Frame
1 year
Title
Reduction in HVPG (Hepatic Venous Pressure Gradient) in both groups
Time Frame
1 year
Title
Reduction in HBV DNA level in both groups.
Time Frame
1 year
Title
Number of patients who will restart alcohol abuse during the follow up period in both groups.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Institute of liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Study the Influence of GCSF on Natural History of Acute On Chronic Liver Failure After the Acute Phase
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