Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05840640
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2023-04-17
Brief Title:
Granulocyte Colony Stimulating Factor Four Week Plus N-Acetyl Cysteine in Severe Alcoholic Hepatitis
Sponsor:
Post Graduate Institute of Medical Education and Research Chandigarh
Organization:
PGIMER
Study Overview
Official Title:
Granulocyte Colony Stimulating Factor Four Week Plus N-Acetyl Cysteine in Severe Alcoholic Hepatitis
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Alcoholic hepatitis is related to very high mortality rate About 40 of the patients died within first 6 months after the detection of the clinical syndrome Therefore it is very essential for proper diagnosis and early treatment In response to acute or chronic liver damage bone marrow derived stem cells can spontaneously populate liver and differentiate into hepatic cells Animal and human studies suggested that injured hepatocyte may be replaced by pluripotent bone marrow cells However this hepatocyte repopulation is highly dependent on varieties of liver injury and therapeutic conditions The studies have suggested Granulocyte-colony stimulating factors G-CSF can regenerate hepatocyte by fusing with hematopoietic cells thereby enhancing the liver histology and survival rate
G-CSF is a cytokine capable to regulate a number of functions in neutrophils In three recent studies mobilization of bone marrow stem cells induced by G-CSF was observed in patients with alcoholic hepatitis In two of these studies there was a survival benefit with the use of G-CSF
Alcoholism leads to decrease in endogenous antioxidant potential Alcoholic liver disease ALD patients show low endogenous antioxidants Chronic ethanol consumption cause selective deficiency in the availability of reduced glutathione GSH in mitochondria has been reported This is due to impaired functioning of GSH transporter from cytosol to mitochondrial matrix The effect on glutathione replenishing potential by N-acetyl cysteine NAC can be used to reduce oxidative stress which also has excellent safety profile Therefore NAC can be used for severe alcoholic hepatitis treatment due to its therapeutic potential factor NAC also inhibit apoptosis and pro-inflammatory cytokine production In a study high doses of intravenous N-acetyl cysteine therapy for 14 days conferred neither survival benefits nor early biological improvement in severe acute alcoholic hepatitis patients with adequate nutritional supportHowever these results must be viewed with caution since the study suffered from a lack of power In a recent study NAC and corticosteroids combination therapy benefits among patients with severe acute alcoholic hepatitis in 1 month survival although the final outcome at 6 month survival was not improved There are no studies on the use of combination therapy of 4 weeks of NAC plus G-CSF in patient with severe alcoholic hepatitis
Therefore the investigators plan to study the safety and efficacy of combination therapy of G-CSF and 4 weeks of NAC in the patients with alcoholic hepatitis
G-CSF is a cytokine capable to regulate a number of functions in neutrophils In three recent studies mobilization of bone marrow stem cells induced by G-CSF was observed in patients with alcoholic hepatitis In two of these studies there was a survival benefit with the use of G-CSF
Alcoholism leads to decrease in endogenous antioxidant potential Alcoholic liver disease ALD patients show low endogenous antioxidants Chronic ethanol consumption cause selective deficiency in the availability of reduced glutathione GSH in mitochondria has been reported This is due to impaired functioning of GSH transporter from cytosol to mitochondrial matrix The effect on glutathione replenishing potential by N-acetyl cysteine NAC can be used to reduce oxidative stress which also has excellent safety profile Therefore NAC can be used for severe alcoholic hepatitis treatment due to its therapeutic potential factor NAC also inhibit apoptosis and pro-inflammatory cytokine production In a study high doses of intravenous N-acetyl cysteine therapy for 14 days conferred neither survival benefits nor early biological improvement in severe acute alcoholic hepatitis patients with adequate nutritional supportHowever these results must be viewed with caution since the study suffered from a lack of power In a recent study NAC and corticosteroids combination therapy benefits among patients with severe acute alcoholic hepatitis in 1 month survival although the final outcome at 6 month survival was not improved There are no studies on the use of combination therapy of 4 weeks of NAC plus G-CSF in patient with severe alcoholic hepatitis
Therefore the investigators plan to study the safety and efficacy of combination therapy of G-CSF and 4 weeks of NAC in the patients with alcoholic hepatitis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None