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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 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-08-20

No results posted yet for this 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.

Conditions

  • Decompensated Cirrhosis

Interventions

DRUG

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

DRUG

Darbepoetin

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

OTHER

Standard Medical Treatment

Standard Medical Treatment

Sponsors & Collaborators

  • Indian Council of Medical Research

    collaborator OTHER_GOV

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Principal Investigators

  • Dr. Shiv Kumar Sarin, DM · Institute of Liver & Biliary Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2031-07-31
Completion
2031-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07131280 on ClinicalTrials.gov