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.

Recruiting now · Not applicable

Conditions studied: Decompensated Liver Cirrhosis

In brief

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 .

Key facts

Study ID

NCT07002827

Run by

Institute of Liver and Biliary Sciences, India

People needed

60

Starts

2025-06-04

Expected to finish

2026-12-30

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-70 years
• Decompensated cirrhosis patients
• Uncomplicated ascites,
• CTP ≤ 9B and MELD <16
• BM Hematopoietic stem cell reserve > 0.4
• Given informed consent

You may not qualify if…

• 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),
• Hemolytic anaemia -Sickle cell disease or thalassemia
• Patients with Grade III ascites /complicated ascites
• Patients with large spleen (size ≥ 15cm)
• Recent variceal bleeding in less than 42 days
• Patients with any focus of sepsis as proven by culture positivity or presence of spontaneous Bacterial Peritonitis (SBP)
• H/o Seizures
• Hepatocellular Carcinoma (HCC) or other malignancy
• Acute Kidney Injury (AKI) with serum Creatinine >1.5 mg/ dl,
• Multi-organ failure,
• Hepatic Encephalopathy or prior history of HE in less than 6months
• HIV seropositivity,
• Uncontrolled essential hypertension, CAD /Stroke
• Massive hydrothorax
• Pregnancy
• Viral etiology of liver disease
• Chronic kidney disease
• Portal vein thrombosis
• Planned for LT
• Bone marrow hematopoietic stem cells < 0.4

Where it is running

• Institute of Liver & Biliary Sciences (ILBS) — New Delhi, National Capital Territory of Delhi, India (enrolling)

Full record on ClinicalTrials.gov

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