Single vs repeated cycles of G-CSF and darbepoetin in early decompensated cirrhosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective randomized trial compares a single cycle of granulocyte colony-stimulating factor (G-CSF) plus darbepoetin to repeated cycles versus standard medical treatment in adults with early decompensated cirrhosis. Participants are 18 to 70 years old with MELD scores under 16 and Child-Pugh B, and have uncomplicated ascites. The study uses open-label with block randomization via an IWRS system at a single center (ILBS, New Delhi) to assess changes in immunometabolic profiles at 6 months, focusing on innate immunity, monocyte and neutrophil distribution and function, and bioenergetic adaptation. Interventions include darbepoetin, G-CSF, lactulose, and albumin. Primary outcomes involve delta changes in immunometabolic markers, with safety and eligibility criteria clearly defined.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Study coordinator: Dr Shreya Singh, MD
• Email: shreyasingh2746@gmail.com
• Phone: 01146300000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.