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

Acute on Chronic Liver Failure Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02788240
• Other study ID #: ILBS-ACLF-008
• Status: Terminated
• Phase: N/A
• First received: March 22, 2016
• Last updated: February 5, 2018
• Start date: May 1, 2016
• Est. completion date: July 15, 2017

Study information

• Verified date: February 2018
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: July 15, 2017
• Est. primary completion date: July 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute on Chronic Liver Failure
• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Liver Failure

Intervention

Drug:
• Peg GCSF

Biological:
• 20% Albumin

Dietary Supplement:
• Nutrition

Other:
• Bowel wash

Drug:
• Terlipressin 1- 4mg,if indicated

• Meropenem or Imepenem, if indicated

• Placebo

Locations

Country	Name	City	State
India	Institute of liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transplant free survival in both groups		1 year
Secondary	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
Secondary	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
Secondary	Reduction in liver disease severity indices like CTP (Child-Turcotte-Pugh) by more than one point in both groups.		1 year
Secondary	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
Secondary	Development of new onset complications such as hepatic encephalopathy in both groups.		1 year
Secondary	Development of new onset complications such as hepatorenal syndrome in both groups.		1 year
Secondary	Development of new onset complications such as sepsis in both groups.		1 year
Secondary	Development of new onset complications such as Hepatocellular carcinoma (HCC).		1 year
Secondary	Total number of CD34 positive cells in histopathological examination of bone marrow in both groups		1 year
Secondary	No of adverse events in both groups		1 year
Secondary	Reduction in HVPG (Hepatic Venous Pressure Gradient) in both groups		1 year
Secondary	Reduction in HBV DNA level in both groups.		1 year
Secondary	Number of patients who will restart alcohol abuse during the follow up period in both groups.		1 year