National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): Single vs Repeated Cycle of Granulocyte Colony-Stimulating Factor (GCSF) & Darbepoetin in Early Decompensated Cirrhosis

NCT07131280 · tracked via the Priya Life Science India tracker

Sponsor

Institute of Liver and Biliary Sciences, India

Phase

Not applicable

Started

2025-09

Last updated

2025-08-20

Condition(s) studied

Decompensated Cirrhosis

Investigational drug(s) / intervention(s)

GcsfDarbepoetinStandard Medical Treatment

Gcsf: G-CSF will be given at a dose of 5 μg/kg s/c at days 1, 2, 3, 4, 5 and then every third and 7th day till day 30

Darbepoetin: Darbepoetin will be given s/c at dose of 40mcg once a week for 1 month

Standard Medical Treatment: Standard Medical Treatment

Study summary

Chronic liver disease is a growing health concern, with limited access to liver transplants. This study addresses the urgent need for alternatives by exploring regenerative therapies, like G-CSF, to boost the liver's natural repair. The goal is to develop safe, effective, and accessible treatments for patients who cannot undergo transplant.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: * Early decompensated cirrhosis patients with MELD \<16 Exclusion Criteria: * Patients with age less than 18 years or more than 65 years * Patients with Grade III ascites * CHILD C cirrhosis * Patients with a known focus of sepsis; spontaneous Bacterial Peritonitis (SBP) * variceal bleeding in past 3months * Hepatocellular Carcinoma (HCC) or other malignancy * Acute Kidney Injury (AKI) with serum Creatinine \>1.5 mg/ dl, multi-organ failure, grade 3 or 4 Hepatic Encephalopathy (HE), * HIV seropositivity * Medically uncontrolled essential hypertension * Pregnancy * Viral etiology of liver disease * Co-existent Hepatitis B, Hepatitis C, HIV * Chronic kidney disease * Lack of informed consent

Primary outcome measure(s)

Transplant-free survival of GCSF + darbepoetin in patients with early decompensated cirrhosis in both groups. — 3 year

Trial sites (1)

Facility	City	Region	Status
Institute of Liver & Biliary Sciences	New Delhi	India

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07131280 on ClinicalTrials.gov ↗ ← All trials in India