Health TrialsbyHealthPanel

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.

ConditionDecompensated Liver Cirrhosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorInstitute of Liver and Biliary Sciences, India

About this trial

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 .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-70 years

Decompensated cirrhosis patients

Uncomplicated ascites,

CTP ≤ 9B and MELD <16

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Darbepoetin

    Drug

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

  • Lactulose

    Drug

    Standard Medical Tretament part

  • Albumin

    Biological/Vaccine

    Standard Medical Tretament part

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Standard Medical treatmentActive comparator 2 interventions
Group B: Single cycle of G-CSF + darbepoetin and standard medical treatmentExperimental treatment 4 interventions
Group C: Three cycles of G-CSF + darbepoetin and standard medical treatment (1-month, 3-month, and 5-month)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Change in innate immunity between the groups.

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

Time frame
6 months

Secondary outcomes

1

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

Time frame
6 months
2

Cumulative incidence of second decompensation in all the groups.

Time frame
6 months & 1 year
3

Transplant-free survival.

Time frame
6 months & 1 year
4

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

Time frame
6 months

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

Source ClinicalTrials.gov
Apply now