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Clinical Trials in India / NCT07002827
Recruiting Not 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.

NCT07002827 · tracked via the Priya Life Science India tracker
Sponsor
Institute of Liver and Biliary Sciences, India
Phase
Not applicable
Started
2025-06-04
Last updated
2026-05-22

Condition(s) studied

Decompensated Liver Cirrhosis

Investigational drug(s) / intervention(s)

DarbepoetinG-CSFLactuloseAlbumin

Darbepoetin: Darbepoetin will be given s/c at dose of 40 mcg once a week (total 4 doses) for 1 month

G-CSF: G-CSF will be given at a dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5 and then every third and 7th day till day 30

Lactulose: Standard Medical Tretament part

Albumin: Standard Medical Tretament part

Study 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 .

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age 18-70 years 2. Decompensated cirrhosis patients 3. Uncomplicated ascites, 4. CTP ≤ 9B and MELD \<16 5. BM Hematopoietic stem cell reserve \> 0.4 6. Given informed consent Exclusion Criteria: 1. Patients with age less than 18 years or more than 65 years 2. Lack of informed consent 3. Patients with a history of serious allergic reactions to the active component, filgrastim, other human granulocyte colony-stimulating factors, or any of the ingredients 4. Evidence of alcoholic hepatitis/active alcohol abuse last intake ≤ 3 months 5. Suspected autoimmune hepatitis (ANA/ASMA-positive in titers 1:80 and/ or IgG 1.5 times upper limit of normal), 6. Hemolytic anaemia -Sickle cell disease or thalassemia 7. Patients with Grade III ascites /complicated ascites 8. Patients with large spleen (size ≥ 15cm) 9. Recent variceal bleeding in less than 42 days 10. Patients with any focus of sepsis as proven by culture positivity or presence of spontaneous Bacterial Peritonitis (SBP) 11. H/o Seizures 12. Hepatocellular Carcinoma (HCC) or other malignancy 13. Acute Kidney Injury (AKI) with serum Creatinine \>1.5 mg/ dl, 14. Multi-organ failure, 15. Hepatic Encephalopathy or prior history of HE in less than 6months 16. HIV seropositivity, 17. Uncontrolled essential hypertension, CAD /Stroke 18. Massive hydrothorax 19. Pregnancy 20. Viral etiology of liver disease 21. Chronic kidney disease 22. Portal vein thrombosis 23. Planned for LT 24. Bone marrow hematopoietic stem cells \< 0.4

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Institute of Liver & Biliary Sciences (ILBS) New Delhi National Capital Territory of Delhi Recruiting

More Institute of Liver and Biliary Sciences, India trials in India

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07002827 on ClinicalTrials.gov ↗ ← All trials in India