Status:
NOT_YET_RECRUITING
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.
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Decompensated Liver Cirrhosis
Eligibility:
All Genders
18-70 years
Phase:
NA
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, CT...
Detailed Description
Aim: To study the efficacy of single vs repeated cycle of Granulocyte Colony Stimulating Factor+ darbopoetin vs standard medical treatmenton immunometabolic profile in patient with early decompensated...
Eligibility Criteria
Inclusion
- Age 18-70 years
- Decompensated cirrhosis patients
- Uncomplicated ascites,
- CTP ≤ 9B and MELD \<16
- BM Hematopoietic stem cell reserve \> 0.4
- Given informed consent
Exclusion
- Patients with age less than 18 years or more than 65 years
- Lack of informed consent
- Patients with a history of serious allergic reactions to the active component, filgrastim, other human granulocyte colony-stimulating factors, or any of the ingredients
- Evidence of alcoholic hepatitis/active alcohol abuse last intake ≤ 3 months
- Suspected autoimmune hepatitis (ANA/ASMA-positive in titers 1:80 and/ or IgG 1.5 times upper limit of normal),
- Hemolytic anaemia -Sickle cell disease or thalassemia
- Patients with Grade III ascites /complicated ascites
- Patients with large spleen (size ≥ 15cm)
- Recent variceal bleeding in less than 42 days
- Patients with any focus of sepsis as proven by culture positivity or presence of spontaneous Bacterial Peritonitis (SBP)
- H/o Seizures
- Hepatocellular Carcinoma (HCC) or other malignancy
- Acute Kidney Injury (AKI) with serum Creatinine \>1.5 mg/ dl,
- Multi-organ failure,
- Hepatic Encephalopathy or prior history of HE in less than 6months
- HIV seropositivity,
- Uncontrolled essential hypertension, CAD /Stroke
- Massive hydrothorax
- Pregnancy
- Viral etiology of liver disease
- Chronic kidney disease
- Portal vein thrombosis
- Planned for LT
- Bone marrow hematopoietic stem cells \< 0.4
Key Trial Info
Start Date :
May 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07002827
Start Date
May 30 2025
End Date
April 30 2026
Last Update
June 4 2025
Active Locations (1)
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1
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India, 110070