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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

ConditionDecompensated Cirrhosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorInstitute of Liver and Biliary Sciences, India

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Early decompensated cirrhosis patients with MELD <16

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gcsf

    Drug

    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

    Drug

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

  • Standard Medical Treatment

    Other intervention

    Standard Medical Treatment

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Three cycles of GCSF+ darbepoetin and standard medical treatmentExperimental treatment 3 interventions
Group B: Single cycle of GCSF+ darbepoetin and standard medical treatmentActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
3 year

Secondary outcomes

1

Transplant-free survival

Time frame
6-month, one year, 2 year and 3 year
2

Proportion of patient developed new-onset of Liver Related Event (such as ascites, hepatic encephalopathy , acute kidney injury, bleed and sepsis) or show mortality in both the groups

Time frame
6-month, one year, 2 year and 3 year
3

Cumulative incidence of sepsis, acute kidney injury or secondary organ dysfunction in both groups

Time frame
6-month, one year, 2 year and 3 year
4

Cumulative incidence of second decompensation

Time frame
6-month, one year, 2 year and 3 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Liver and Biliary Sciences, India

Lead sponsor

Indian Council of Medical Research

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: