National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): Single vs Repeated Cyc… (NCT07131280) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): Single vs Repeated Cycle of Granulocyte Colony-Stimulating Factor (GCSF) & Darbepoetin in Early Decompensated Cirrhosis
India110 participantsStarted 2025-09
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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
What they're measuring
1
Transplant-free survival of GCSF + darbepoetin in patients with early decompensated cirrhosis in both groups.
Timeframe: 3 year
Trial details
NCT IDNCT07131280
SponsorInstitute of Liver and Biliary Sciences, India