Effect of Single vs Repeated Cycles of a Combination of Granulocyte Colony Stimulating Factor and… (NCT07002827) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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.
India60 participantsStarted 2025-05-30
Plain-language summary
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 .
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Age 18-70 years
✓. Decompensated cirrhosis patients
✓. Uncomplicated ascites,
✓. CTP ≤ 9B and MELD \<16
✓. BM Hematopoietic stem cell reserve \> 0.4
✓. Given informed consent
Exclusion criteria
✕. Patients with age less than 18 years or more than 65 years
✕. Lack of informed consent
✕. Patients with a history of serious allergic reactions to the active component, filgrastim, other human granulocyte colony-stimulating factors, or any of the ingredients
✕. Evidence of alcoholic hepatitis/active alcohol abuse last intake ≤ 3 months
✕. Suspected autoimmune hepatitis (ANA/ASMA-positive in titers 1:80 and/ or IgG 1.5 times upper limit of normal),
What they're measuring
1
Change in innate immunity between the groups.
Timeframe: 6 months
Trial details
NCT IDNCT07002827
SponsorInstitute of Liver and Biliary Sciences, India