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 | Not Yet Recruiting

• 1 other identifier: ILBS-Cirrhosis-75
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

GCSF; Decompensated cirrhosis; Darbepoetin

Outcome Measures

Primary Outcomes (1)

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

  3 year

Secondary Outcomes (11)

• Transplant-free survival

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

• 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

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

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

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

• Cumulative incidence of second decompensation

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

• Improvement in liver disease severity indices, including the Child-Turcotte-Pugh (CTP) score (ΔCTP).

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

Study Arms (2)

Three cycles of GCSF+ darbepoetin and standard medical treatment

EXPERIMENTAL

Patient randomize for Three cycle of GCSF+ darbepoetin together with standard medical treatment, 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 based on hematological response and darbepoetin will be given s/c at dose of 40mcg once a week (total 4 doses) for 1 month. Second cycle of GCSF+ darbepoetin will be given after 1 month of completion of first cycle that is at month 3 and third cycle will be given 1 month after completion of 2nd cycle that is at 5th month. All patients will receive the standard medical treatment.

Drug: Gcsf; Drug: Darbepoetin; Other: Standard Medical Treatment

Single cycle of GCSF+ darbepoetin and standard medical treatment

ACTIVE COMPARATOR

Patient randomize for Single cycle of GCSF+ darbepoetin together with standard medical treatment, 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 based on hematological response and darbepoetin will be given s/c at dose of 40mcg once a week (total 4 doses) for 1 month. All patients will receive the standard medical treatment.

Drug: Gcsf; Drug: Darbepoetin; Other: Standard Medical Treatment

Interventions

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

Single cycle of GCSF+ darbepoetin and standard medical treatment; Three cycles of GCSF+ darbepoetin and standard medical treatment

Darbepoetin DRUG

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

Single cycle of GCSF+ darbepoetin and standard medical treatment; Three cycles of GCSF+ darbepoetin and standard medical treatment

Standard Medical Treatment OTHER

Standard Medical Treatment

Single cycle of GCSF+ darbepoetin and standard medical treatment; Three cycles of GCSF+ darbepoetin and standard medical treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Early decompensated cirrhosis patients with MELD \<16

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead
• Indian Council of Medical Research: collaborator

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, 110070, India

Location

MeSH Terms

Interventions

Granulocyte Colony-Stimulating Factor; Darbepoetin alfa

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Erythropoietin

Study Officials

• Dr. Shiv Kumar Sarin, DM

  Institute of Liver & Biliary Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Anupam Kumar, PhD

CONTACT

01146300000; dr.anupamkumar.ilbs@gmail.com

Fagun Sharma, M.Sc.

CONTACT

01146300000; fagun.30sharma@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: August 20, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: August 20, 2025

Record last verified: 2025-08

Locations

IN (1)