Effect of Single vs Repeated Cycles of a Combination of Granulocyte Colony Stimulating Factor and Darbepoetin vs Standard Medical Treatment on Immunometabolic Profile in Patient With Early Decompensated Cirrhosis.

NCT07002827 | Not Yet Recruiting

• 1 other identifier: ILBS-Cirrhosis-73
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Exogenous growth factor-mobilized bone marrow (BM) stem cells(G-CSF) and DARBEPOETIN use have shown a differential response in the management of decompensated cirrhosis (DC) with improved survival, CTP and MELD scores. This study was designed to evaluate potential clinical benefit of repeated cycles of granulocyte-colony stimulating factor (G-CSF) and DARBEPOETIN versus single cycle on delta change in immunometabolic profile of patients at 6 months assessed in terms of -Change in innate immunity -Monocyte, neutrophils -distribution , function and bioenergetic adaptation .

Conditions

Decompensated Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Change in innate immunity between the groups.

  Innate immunity -Monocyte, neutrophils -distribution , function and bioenergetic adaptation

  6 months

Secondary Outcomes (10)

• Proportion of participants developed new-onset of LRE (such as ascites, HE, AKI, bleed and sepsis) or show mortality in all the groups.

  6 months

• Cumulative incidence of second decompensation in all the groups.

  6 months & 1 year

• Transplant-free survival.

  6 months & 1 year

• Number of participants with improvement in liver disease severity indices (CTP).

  6 months

• Number of participants with improvement in liver disease severity indices (MELD).

  6 months

Study Arms (3)

Standard Medical treatment

ACTIVE COMPARATOR

Standard medical therapy including lactulose, bowel enema and albumin will be continued in both groups.

Drug: Lactulose; Biological: Albumin

Single cycle of G-CSF + darbepoetin and standard medical treatment

EXPERIMENTAL

* 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 will be given s/c at dose of 40 mcg once a week (total 4 doses) for 1 month. * Standard medical therapy including lactulose, bowel enema and albumin will be continued in both groups.

Drug: Darbepoetin; Drug: G-CSF; Drug: Lactulose; Biological: Albumin

Three cycles of G-CSF + darbepoetin and standard medical treatment (1-month, 3-month, and 5-month)

EXPERIMENTAL

* 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 will be given s/c at dose of 40 mcg once a week (total 4 doses) for 1 month. * Standard medical therapy including lactulose, bowel enema and albumin will be continued in both groups.

Drug: Darbepoetin; Drug: G-CSF; Drug: Lactulose; Biological: Albumin

Interventions

Darbepoetin DRUG

Darbepoetin will be given s/c at dose of 40 mcg once a week (total 4 doses) for 1 month

Single cycle of G-CSF + darbepoetin and standard medical treatment; Three cycles of G-CSF + darbepoetin and standard medical treatment (1-month, 3-month, and 5-month)

G-CSF 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 G-CSF + darbepoetin and standard medical treatment; Three cycles of G-CSF + darbepoetin and standard medical treatment (1-month, 3-month, and 5-month)

Lactulose DRUG

Standard Medical Tretament part

Single cycle of G-CSF + darbepoetin and standard medical treatment; Standard Medical treatment; Three cycles of G-CSF + darbepoetin and standard medical treatment (1-month, 3-month, and 5-month)

Albumin BIOLOGICAL

Standard Medical Tretament part

Single cycle of G-CSF + darbepoetin and standard medical treatment; Standard Medical treatment; Three cycles of G-CSF + darbepoetin and standard medical treatment (1-month, 3-month, and 5-month)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years
• Decompensated cirrhosis patients
• Uncomplicated ascites,
• CTP ≤ 9B and MELD \<16
• BM Hematopoietic stem cell reserve \> 0.4
• Given informed consent

You may not qualify if:

• Patients with age less than 18 years or more than 65 years
• Lack of informed consent
• Patients with a history of serious allergic reactions to the active component, filgrastim, other human granulocyte colony-stimulating factors, or any of the ingredients
• Evidence of alcoholic hepatitis/active alcohol abuse last intake ≤ 3 months
• Suspected autoimmune hepatitis (ANA/ASMA-positive in titers 1:80 and/ or IgG 1.5 times upper limit of normal),
• Hemolytic anaemia -Sickle cell disease or thalassemia
• Patients with Grade III ascites /complicated ascites
• Patients with large spleen (size ≥ 15cm)
• Recent variceal bleeding in less than 42 days
• Patients with any focus of sepsis as proven by culture positivity or presence of spontaneous Bacterial Peritonitis (SBP)
• H/o Seizures
• Hepatocellular Carcinoma (HCC) or other malignancy
• Acute Kidney Injury (AKI) with serum Creatinine \>1.5 mg/ dl,
• Multi-organ failure,
• Hepatic Encephalopathy or prior history of HE in less than 6months

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Interventions

Darbepoetin alfa; Granulocyte Colony-Stimulating Factor; Lactulose; Albumins

Intervention Hierarchy (Ancestors)

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

Study Officials

• Dr Manoj Kumar Sharma, DM

  Institute of Liver and Biliary Sciences

  STUDY DIRECTOR

Central Study Contacts

Dr Shreya Singh, MD

CONTACT

01146300000; shreyasingh2746@gmail.com

Dr Manoj Kumar Sharma, DM

CONTACT

01146300000; manojkumardm@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: May 3, 2025
• First Posted: June 4, 2025
• Study Start: May 30, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

IN (1)