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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.

RecruitingNAAges 18 Years - 70 YearsAllInstitute of Liver and Biliary Sciences, India
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In plain words

What the trial is, and whether it could suit you

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 .

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age 18-70 years 2. Decompensated cirrhosis patients 3. Uncomplicated ascites, 4. CTP โ‰ค 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 โ‰ค 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 โ‰ฅ 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
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What it tests

  • Darbepoetin
  • G-CSF
  • Lactulose
  • Albumin
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Where

1 site
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, India
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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