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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Darbepoetin, G-CSF, Lactulose, Albumin.
- Who it may be relevant to
- Registry conditions: Decompensated Liver Cirrhosis. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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 -A Pilot Randomised Controlled Trial.
Overview
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 .
Detailed description
Aim: To study the efficacy of single vs repeated cycle of Granulocyte Colony Stimulating Factor+ darbopoetin vs standard medical treatmenton immunometabolic profile in patient with early decompensated cirrhosis
Study population:
* Age 18-70 years * Early decompensated cirrhosis MELD \< 16 , CTP \< 9B * Uncomplicated ascites * A Prospective Randomized Controlled Trial. * Single Centre. * Open label. * Block Randomization will be done , it will be implemented by IWRS method. * The study will be conducted in Department of Hepatology, ILBS.
Interventions
- Drug Darbepoetin
Darbepoetin will be given s/c at dose of 40 mcg once a week (total 4 doses) for 1 month - Drug G-CSF
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 Lactulose
Standard Medical Tretament part - Biological Albumin
Standard Medical Tretament part
Primary outcome measures
- Change in innate immunity between the groups. [Time frame: 6 months]
Secondary outcome measures (10)
- 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]
- Cumulative incidence of second decompensation in all the groups. [Time frame: 6 months & 1 year]
- Transplant-free survival. [Time frame: 6 months & 1 year]
- Number of participants with improvement in liver disease severity indices (CTP). [Time frame: 6 months]
- Number of participants with improvement in liver disease severity indices (MELD). [Time frame: 6 months]
- Number of participants with change in adaptive immunity(T-cell, B-cell and NK cells distribution only ) [Time frame: 6 months]
- Number of participants with change in inflammation (a panel of pro and anti-inflammatory cytokines). [Time frame: 6 months]
- Change in gcsf levels and EPO levels at baseline and completion of each cycle. [Time frame: 6 months]
- Proportion of participants completing treatment without major adverse effects; [Time frame: 6 months]
- Number of participants with change in peripheral blood CD34+ Hematopoietic Stem Cells count at 6months. [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Age 18-70 years
- Decompensated cirrhosis patients
- Uncomplicated ascites,
- CTP ≤ 9B and MELD <16
- BM Hematopoietic stem cell reserve > 0.4
- Given informed consent
Exclusion criteria
- 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
- HIV seropositivity,
- Uncontrolled essential hypertension, CAD /Stroke
- Massive hydrothorax
- Pregnancy
- Viral etiology of liver disease
- Chronic kidney disease
- Portal vein thrombosis
- Planned for LT
- Bone marrow hematopoietic stem cells < 0.4
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
India · 1 center
- Institute of Liver & Biliary Sciences (ILBS) — New Delhi
Identifiers
NCT: NCT07002827 · ILBS-Cirrhosis-73