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Effect of Single vs Repeated Cycles of a Combination of Granulocyte Colony Stimulating Factor and Darbepoetin vs Standard Medical Treatment on Immunometabolic Profile in Patient With Early Decompensated Cirrhosis -A Pilot Randomised Controlled Trial.
Exogenous growth factor-mobilized bone marrow (BM) stem cells(G-CSF) and DARBEPOETIN use have shown a differential response in the management of decompensated cirrhosis (DC) with improved survival, CTP and MELD scores. This study was designed to evaluate potential clinical benefit of repeated cycles of granulocyte-colony stimulating factor (G-CSF) and DARBEPOETIN versus single cycle on delta change in immunometabolic profile of patients at 6 months assessed in terms of -Change in innate immunity -Monocyte, neutrophils -distribution , function and bioenergetic adaptation .
Aim: To study the efficacy of single vs repeated cycle of Granulocyte Colony Stimulating Factor+ darbopoetin vs standard medical treatmenton immunometabolic profile in patient with early decompensated cirrhosis Study population: * Age 18-70 years * Early decompensated cirrhosis MELD \< 16 , CTP \< 9B * Uncomplicated ascites * A Prospective Randomized Controlled Trial. * Single Centre. * Open label. * Block Randomization will be done , it will be implemented by IWRS method. * The study will be conducted in Department of Hepatology, ILBS.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India
Start Date
May 30, 2025
Primary Completion Date
April 30, 2026
Completion Date
April 30, 2026
Last Updated
June 4, 2025
60
ESTIMATED participants
Darbepoetin
DRUG
G-CSF
DRUG
Lactulose
DRUG
Albumin
BIOLOGICAL
Lead Sponsor
Institute of Liver and Biliary Sciences, India
NCT06212635
NCT03472742
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT03529136