NCT07002827 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.
| NCT ID | NCT07002827 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Liver and Biliary Sciences, India |
| Condition | Decompensated Liver Cirrhosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-06-04 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-06-04 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Dr Manoj Kumar Sharma, DM
STUDY DIRECTOR
Institute of Liver and Biliary Sciences
Frequently Asked Questions
Who can join the NCT07002827 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Decompensated Liver Cirrhosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07002827 currently recruiting?
Yes, NCT07002827 is actively recruiting participants. Contact the research team at shreyasingh2746@gmail.com for enrollment information.
Where is the NCT07002827 trial being conducted?
This trial is being conducted at New Delhi, India.
Who is sponsoring the NCT07002827 clinical trial?
NCT07002827 is sponsored by Institute of Liver and Biliary Sciences, India. The principal investigator is Dr Manoj Kumar Sharma, DM at Institute of Liver and Biliary Sciences. The trial plans to enroll 60 participants.