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.
Key facts
- Where
- New Delhi, IndiaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07002827, who can take part
Where in India
- Institute of Liver & Biliary Sciences (ILBS)New Delhi, IndiaContact: Dr Shreya Singh, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Institute of Liver and Biliary Sciences, India
- Trial code
- NCT07002827
- Record updated
- 22 May 2026
- Original description
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 .Read full original descriptionShow less
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 .
Inclusion: 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: Hepatic Encephalopathy or prior history of HE in less than 6months; 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),; Hemolytic anaemia -Sickle cell disease or thalassemia; Recent variceal bleeding in less than 42 days; H/o Seizures; Hepatocellular Carcinoma (HCC) or other malignancy; Multi-organ failure,; HIV seropositivity,; Uncontrolled essential hypertension, CAD /Stroke; Viral etiology of liver disease; Chronic kidney disease; Portal vein thrombosis; Acute Kidney Injury (AKI) with serum Creatinine >1.5 mg/ dl,; Patients with age less than 18 years or more than 65 years; Lack of informed consent; Patients with Grade III ascites /complicated ascites; Patients with large spleen (size ≥ 15cm); Patients with any focus of sepsis as proven by culture positivity or presence of spontaneous Bacterial Peritonitis (SBP); Massive hydrothorax; Pregnancy; Planned for LT; Bone marrow hematopoietic stem cells < 0.4.