Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: Single cycle of G-CSF with darbepoetin and standard medical treatment: 1. G-CSF will be given at a dose of 5 g per kg subcutaneous at days 1, 2, 3, 4, 5 and then every third and 7th da
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18 to 70 years 2. Decompensated cirrhosis patients 3. Uncomplicated ascites, 4. CTP less than equals to 9B and MELD less than 16 5. BM Hematopoietic stem cell reserve more than 0.4 6. Given informed consent
Exclusion criteria
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 or active alcohol abuse last intake less than equals to 3 months 5. Suspected autoimmune hepatitis (ANA or 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 more than equals to 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 more than 1.5 mg per 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 less than 0.4
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the effect of single vs repeated cycle GCSF+ darbepoetin therapy at 6 months on the - Change in innate immunity Monocyte, neutrophils distribution , function and bioenergetic adaptation . Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patient developed new-onset of LRE (such as ascites, HE, AKI, bleed and sepsis) or show mortality in all the groupsTimepoint: 6 months;Cumulative incidence of second decompensation at 6-month and one year in all the groupsTimepoint: 6 months;6-month and one year transplant-free survivalTimepoint: 6 months;Improvement in liver disease severity indices (CTP, MELD)Timepoint: 6 months;Change in adaptive immunity(T-cell, B-cell and NK cells distribution only )Timepoint: 6 months;Change in inflammation (a panel of pro and anti-inflammatory cytokines)Timepoint: 6 months;Change in gcsf levels and EPO levels at baseline and completion of each cycleTimepoint: 6 months;Proportion of patients completing treatment without major adverse effects;Timepoint: 6 months;Change in peripheral blood CD34+ Hematopoietic Stem Cells count at 6monthsTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Manoj Kumar Sharma
Institute of Liver and Biliary Sciences
Outcome results
None listed