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.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorInstitute of Liver and Biliary Sciences, India

About this 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 .

Eligibility criteria

Qualifiers

Age 18-70 years

Decompensated cirrhosis patients

Uncomplicated ascites,

CTP ≤ 9B and MELD <16

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Darbepoetin
  • G-CSF
  • Lactulose
  • Albumin

Treatment groups

60 Participants
are divided into 3 treatment groups