Decompensated Liver CirrhosisNCT07002827
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 study testing Darbepoetin, G-CSF and Lactulose in people with Decompensated Liver Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Decompensated Liver Cirrhosis
- What is being tested?
- Darbepoetin, G-CSF and Lactulose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 4 Jun 2025to 30 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years
- Decompensated cirrhosis patients
- Uncomplicated ascites,
- CTP ≤ 9B and MELD <16
- BM Hematopoietic stem cell reserve > 0.4
- Given informed consent
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, 110070
Dr Shreya Singh, MD, 01146300000, shreyasingh2746@gmail.com
About this study
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.
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 .
Read the 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.
- Conditions
- Decompensated Liver Cirrhosis
- Being tested
- Darbepoetin, G-CSF, Lactulose, Albumin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarbepoetinDrug
Darbepoetin will be given s/c at dose of 40 mcg once a week (total 4 doses) for 1 month
G-CSFDrug
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
LactuloseDrug
Standard Medical Tretament part
AlbuminBiological
Standard Medical Tretament part
| Study group | Role | What they receive |
|---|---|---|
| Standard Medical treatment | Active comparator | Standard medical therapy including lactulose, bowel enema and albumin will be continued in both groups. Receives: 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. Receives: 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. Receives: Drug: Darbepoetin; Drug: G-CSF; Drug: Lactulose; Biological: Albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in innate immunity between the groups.
Innate immunity -Monocyte, neutrophils -distribution , function and bioenergetic adaptation
Measured: 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.
Measured: 6 months
Cumulative incidence of second decompensation in all the groups.
Measured: 6 months & 1 year
Transplant-free survival.
Measured: 6 months & 1 year
Number of participants with improvement in liver disease severity indices (CTP).
Measured: 6 months
Number of participants with improvement in liver disease severity indices (MELD).
Measured: 6 months
Number of participants with change in adaptive immunity(T-cell, B-cell and NK cells distribution only )
Measured: 6 months
Number of participants with change in inflammation (a panel of pro and anti-inflammatory cytokines).
Measured: 6 months
Change in gcsf levels and EPO levels at baseline and completion of each cycle.
Measured: 6 months
Proportion of participants completing treatment without major adverse effects;
Measured: 6 months
Number of participants with change in peripheral blood CD34+ Hematopoietic Stem Cells count at 6months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start4 Jun 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompensated Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Manoj Kumar Sharma, DM, Study director, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002827
- Sponsor's protocol ID
- ILBS-Cirrhosis-73
- Status last verified
- May 2026
- First submitted
- 3 May 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided