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
- Are there results?
- Not yet: the study is under way
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
Show all 24Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07002827
- Acronym / sponsor ID
- ILBS-Cirrhosis-73
- Conditions
- Decompensated Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Medical treatment | Active comparator | Drug: Lactulose, Biological: AlbuminStandard medical therapy including lactulose, bowel enema and albumin will be continued in both groups. |
| Single cycle of G-CSF + darbepoetin and standard medical treatment | Experimental | Drug: Darbepoetin, Drug: G-CSF, Drug: Lactulose, Biological: Albumin* 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. |
| Three cycles of G-CSF + darbepoetin and standard medical treatment (1-month, 3-month, and 5-month) | Experimental | Drug: Darbepoetin, Drug: G-CSF, Drug: Lactulose, Biological: Albumin* 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-70 years
- Decompensated cirrhosis patients
- Uncomplicated ascites,
- CTP ≤ 9B and MELD <16
- BM Hematopoietic stem cell reserve > 0.4
Key exclusion criteria (24 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DarbepoetinDarbepoetin will be given s/c at dose of 40 mcg once a week (total 4 doses) for 1 month | Drug | 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-CSFG-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 | 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) |
| LactuloseStandard Medical Tretament part | Drug | 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) |
| AlbuminStandard Medical Tretament part | Biological | 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) |
Primary outcome
Change in innate immunity between the groups.
Time frame: 6 months
Innate immunity -Monocyte, neutrophils -distribution , function and bioenergetic adaptation
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Manoj Kumar Sharma, DM study director
Institute of Liver and Biliary Sciences, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Shreya Singh, MD (01146300000, shreyasingh2746@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in innate immunity between the groups. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.