Clinical trial NCT02788240: 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
Overall status: TERMINATED
Phase: NA
Conditions: Acute on Chronic Liver Failure
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2016-06-02
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Transplant free survival in both groups
timeFrame: 1 year
Secondary outcomes:
measure: Quantitative assessment of CD34 positive cells in serum in both groups.
timeFrame: 1 year
measure: Quantitative assessment of CD34 positive cells in liver biopsy samples in both groups.
timeFrame: 1 year
measure: Reduction in liver disease severity indices like CTP (Child-Turcotte-Pugh) by more than one point in both groups.
timeFrame: 1 year
measure: Reduction in liver disease severity indices like MELD Na ((Model for End Stage liver disease) by more than 2 points in both groups.
timeFrame: 1 year
measure: Development of new onset complications such as hepatic encephalopathy in both groups.
timeFrame: 1 year
measure: Development of new onset complications such as hepatorenal syndrome in both groups.
timeFrame: 1 year
measure: Development of new onset complications such as sepsis in both groups.
timeFrame: 1 year
measure: Development of new onset complications such as Hepatocellular carcinoma (HCC).
timeFrame: 1 year
measure: Total number of CD34 positive cells in histopathological examination of bone marrow in both groups
timeFrame: 1 year
measure: No of adverse events in both groups
timeFrame: 1 year
measure: Reduction in HVPG (Hepatic Venous Pressure Gradient) in both groups
timeFrame: 1 year
measure: Reduction in HBV DNA level in both groups.
timeFrame: 1 year
measure: Number of patients who will restart alcohol abuse during the follow up period in both groups.
timeFrame: 1 year
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of liver and Biliary Sciences
state: Delhi
Study officials:
References: