Decompensated CirrhosisNC-CHRMNCT07131280
National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM): Single vs Repeated Cycle of Granulocyte Colony-Stimulating Factor (GCSF) & Darbepoetin in Early Decompensated Cirrhosis
A study testing Gcsf, Darbepoetin and Standard Medical Treatment in people with Decompensated Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Chronic liver disease is a growing health concern, with limited access to liver transplants. This study addresses the urgent need for alternatives by exploring regenerative therapies, like G-CSF, to boost the liver's natural repair. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Decompensated Cirrhosis
- What is being tested?
- Gcsf, Darbepoetin and Standard Medical Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2025to Dec 2031
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Early decompensated cirrhosis patients with MELD <16
Who cannot join
- Patients with age less than 18 years or more than 65 years
- Patients with Grade III ascites
- CHILD C cirrhosis
- Patients with a known focus of sepsis; spontaneous Bacterial Peritonitis (SBP)
- variceal bleeding in past 3months
- Hepatocellular Carcinoma (HCC) or other malignancy
Show all 14Show fewer
- Acute Kidney Injury (AKI) with serum Creatinine >1.5 mg/ dl, multi-organ failure, grade 3 or 4 Hepatic Encephalopathy (HE),
- HIV seropositivity
- Medically uncontrolled essential hypertension
- Pregnancy
- Viral etiology of liver disease
- Co-existent Hepatitis B, Hepatitis C, HIV
- Chronic kidney disease
- Lack of informed consent
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
Institute of Liver & Biliary Sciences
New Delhi, 110070
Dr. Anupam Kumar, PhD, 01146300000, dr.anupamkumar.ilbs@gmail.com
About this study
Official title: National Collaborative Centre for Hepatic Regenerative Medicine(NC-CHRM): To Study the Efficacy of Single vs Repeated Cycle of GCSF+ Darbepoetin in Long Term Transplant Free Management of Patient With Early Decompensated Cirrhosis
Chronic liver disease is a growing health concern, with limited access to liver transplants. This study addresses the urgent need for alternatives by exploring regenerative therapies, like G-CSF, to boost the liver's natural repair. The goal is to develop safe, effective, and accessible treatments for patients who cannot undergo transplant.
Read the detailed description
The incidence of deaths from chronic liver diseases (CLD) and cirrhosis are rapidly increasing globally, including India. Liver transplant is the only curative option. Unfortunately, transplant is often not feasible. There is a need for nearly 100,000 liver transplants every year in India, though, only about 2,500 transplants are being done at present across the country. There is therefore, a huge unmet need of developing non-transplant options for chronic liver disease patients. In this regard emerging science of regenerative therapy holds great promises but therapeutic benefit of these therapies is limited due to lack of clinical validation.
Novelty: Cirrhosis as a result of hepatitis B and C can regress with effective antiviral therapy. Therapeutic options for patients with cryptogenic or alcoholic cirrhosis are, however, limited. With limited options for transplant. Liver failure is failure of regeneration hence, potentiating native liver repair and regeneration can serve as potential non-transplant approaches. Growth factors {like GCSF, darbepoetin (EPO) have shown survival benefits with improve liver repair and regeneration in clinical trials by us (Gastroenterology 2012, 2015, Liver Int. 2019; Hepatology 2021) and others, however the effect is transient. In the proposed National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM) we will use this novel regenerative medicine approaches GCSF therapy (for management of chronic liver failure) to develop safe and effective regenerative therapy clinical protocol for transplant free management of liver failure in cirrhosis. Using integrated cellular, molecular and functional analysis we will also establish their mechanism of action and identify biomarker to access therapeutic response.
- Conditions
- Decompensated Cirrhosis
- Being tested
- Gcsf, Darbepoetin, Standard Medical Treatment
- Keywords
- GCSF, Decompensated cirrhosis, Darbepoetin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GcsfDrug
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
DarbepoetinDrug
Darbepoetin will be given s/c at dose of 40mcg once a week for 1 month
Standard Medical TreatmentOther
Standard Medical Treatment
| Study group | Role | What they receive |
|---|---|---|
| Three cycles of GCSF+ darbepoetin and standard medical treatment | Experimental | Patient randomize for Three cycle of GCSF+ darbepoetin together with standard medical treatment, 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 based on hematological response and darbepoetin will be given s/c at dose of 40mcg once a week (total 4 doses) for 1 month. Second cycle of GCSF+ darbepoetin will be given after 1 month of completion of first cycle that is at month 3 and third cycle will be given 1 month after completion of 2nd cycle that is at 5th month. All patients will receive the standard medical treatment. Receives: Drug: Gcsf; Drug: Darbepoetin; Other: Standard Medical Treatment |
| Single cycle of GCSF+ darbepoetin and standard medical treatment | Active comparator | Patient randomize for Single cycle of GCSF+ darbepoetin together with standard medical treatment, 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 based on hematological response and darbepoetin will be given s/c at dose of 40mcg once a week (total 4 doses) for 1 month. All patients will receive the standard medical treatment. Receives: Drug: Gcsf; Drug: Darbepoetin; Other: Standard Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplant-free survival of GCSF + darbepoetin in patients with early decompensated cirrhosis in both groups.
Measured: 3 year
Secondary outcomes (11)
Transplant-free survival
Measured: 6-month, one year, 2 year and 3 year
Proportion of patient developed new-onset of Liver Related Event (such as ascites, hepatic encephalopathy , acute kidney injury, bleed and sepsis) or show mortality in both the groups
Measured: 6-month, one year, 2 year and 3 year
Cumulative incidence of sepsis, acute kidney injury or secondary organ dysfunction in both groups
Measured: 6-month, one year, 2 year and 3 year
Cumulative incidence of second decompensation
Measured: 6-month, one year, 2 year and 3 year
Improvement in liver disease severity indices, including the Child-Turcotte-Pugh (CTP) score (ΔCTP).
Measured: 6-month, one year, 2 year and 3 year
Improvement in liver disease severity indice like Model for End-Stage Liver Disease (MELD) score (ΔMELD).
Measured: 6-month, one year, 2 year and 3 year
Proportion of patients completing treatment without major adverse effects
Adverse effects will be graded in accordance to CTCAE
Measured: 6-month, one year, 2 year and 3 year
Impact on liver injury (assessed by AST and ALT levels in blood).
Measured: 6-month, one year, 2 year and 3 year
Impact on fibrosis (evaluated using Masson's Trichome stain and the Enhanced Liver Fibrosis [ELF] score).
Measured: 6-month, one year, 2 year and 3 year
Impact on regeneration (measured by plasma Alpha-Fetoprotein levels).
Measured: 6-month, one year, 2 year and 3 year
Impact on bone marrow stem cell reserve (CD34⁺ cell count in peripheral blood)
Measured: One year, 2 year and 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionJul 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompensated 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Council of Medical Research
- Responsible party
- Sponsor
- Investigators
- Dr. Shiv Kumar Sarin, DM, Principal investigator, Institute of Liver & Biliary Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131280
- Sponsor's protocol ID
- ILBS-Cirrhosis-75
- Acronym
- NC-CHRM
- Status last verified
- Aug 2025
- First submitted
- 11 Jul 2025
- Last updated
- 20 Aug 2025
- 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 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Collaborative Centre for Hepatic Regenerative Medicine(NC-CHRM): To Study the Efficacy of Single vs Repeated Cycle of GCSF+ Darbepoetin in Long Term Transplant Free Management of Patient With Early Decompensated Cirrhosis
- ClinicalTrials.gov ID
- NCT07131280
- Acronym / sponsor ID
- NC-CHRM / ILBS-Cirrhosis-75
- Conditions
- Decompensated Cirrhosis
- Keywords
- GCSF, Decompensated cirrhosis, Darbepoetin
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Collaborators
- Indian Council of Medical Research
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jul 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 20 Aug 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.
Chronic liver disease is a growing health concern, with limited access to liver transplants. This study addresses the urgent need for alternatives by exploring regenerative therapies, like G-CSF, to boost the liver's natural repair. The goal is to develop safe, effective, and accessible treatments for patients who cannot undergo transplant.
Detailed description
The incidence of deaths from chronic liver diseases (CLD) and cirrhosis are rapidly increasing globally, including India. Liver transplant is the only curative option. Unfortunately, transplant is often not feasible. There is a need for nearly 100,000 liver transplants every year in India, though, only about 2,500 transplants are being done at present across the country. There is therefore, a huge unmet need of developing non-transplant options for chronic liver disease patients. In this regard emerging science of regenerative therapy holds great promises but therapeutic benefit of these therapies is limited due to lack of clinical validation.
Novelty: Cirrhosis as a result of hepatitis B and C can regress with effective antiviral therapy. Therapeutic options for patients with cryptogenic or alcoholic cirrhosis are, however, limited. With limited options for transplant. Liver failure is failure of regeneration hence, potentiating native liver repair and regeneration can serve as potential non-transplant approaches. Growth factors {like GCSF, darbepoetin (EPO) have shown survival benefits with improve liver repair and regeneration in clinical trials by us (Gastroenterology 2012, 2015, Liver Int. 2019; Hepatology 2021) and others, however the effect is transient. In the proposed National Collaborative Centre for Hepatic Regenerative Medicine (NC-CHRM) we will use this novel regenerative medicine approaches GCSF therapy (for management of chronic liver failure) to develop safe and effective regenerative therapy clinical protocol for transplant free management of liver failure in cirrhosis. Using integrated cellular, molecular and functional analysis we will also establish their mechanism of action and identify biomarker to access therapeutic response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Three cycles of GCSF+ darbepoetin and standard medical treatment | Experimental | Drug: Gcsf, Drug: Darbepoetin, Other: Standard Medical TreatmentPatient randomize for Three cycle of GCSF+ darbepoetin together with standard medical treatment, 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 based on hematological response and darbepoetin will be given s/c at dose of 40mcg once a week (total 4 doses) for 1 month. Second cycle of GCSF+ darbepoetin will be given after 1 month of completion of first cycle that is at month 3 and third cycle will be given 1 month after completion of 2nd cycle that is at 5th month. All patients will receive the standard medical treatment. |
| Single cycle of GCSF+ darbepoetin and standard medical treatment | Active comparator | Drug: Gcsf, Drug: Darbepoetin, Other: Standard Medical TreatmentPatient randomize for Single cycle of GCSF+ darbepoetin together with standard medical treatment, 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 based on hematological response and darbepoetin will be given s/c at dose of 40mcg once a week (total 4 doses) for 1 month. All patients will receive the standard medical treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Early decompensated cirrhosis patients with MELD <16
Key exclusion criteria (14 listed)
- Patients with age less than 18 years or more than 65 years
- Patients with Grade III ascites
- CHILD C cirrhosis
- Patients with a known focus of sepsis; spontaneous Bacterial Peritonitis (SBP)
- variceal bleeding in past 3months
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 |
|---|---|---|
| GcsfG-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 GCSF+ darbepoetin and standard medical treatment, Three cycles of GCSF+ darbepoetin and standard medical treatment |
| DarbepoetinDarbepoetin will be given s/c at dose of 40mcg once a week for 1 month | Drug | Single cycle of GCSF+ darbepoetin and standard medical treatment, Three cycles of GCSF+ darbepoetin and standard medical treatment |
| Standard Medical TreatmentStandard Medical Treatment | Other | Single cycle of GCSF+ darbepoetin and standard medical treatment, Three cycles of GCSF+ darbepoetin and standard medical treatment |
Primary outcome
Transplant-free survival of GCSF + darbepoetin in patients with early decompensated cirrhosis in both groups.
Time frame: 3 year
11 secondary outcomes
Transplant-free survival
Time frame: 6-month, one year, 2 year and 3 year
Proportion of patient developed new-onset of Liver Related Event (such as ascites, hepatic encephalopathy , acute kidney injury, bleed and sepsis) or show mortality in both the groups
Time frame: 6-month, one year, 2 year and 3 year
Cumulative incidence of sepsis, acute kidney injury or secondary organ dysfunction in both groups
Time frame: 6-month, one year, 2 year and 3 year
Cumulative incidence of second decompensation
Time frame: 6-month, one year, 2 year and 3 year
Improvement in liver disease severity indices, including the Child-Turcotte-Pugh (CTP) score (ΔCTP).
Time frame: 6-month, one year, 2 year and 3 year
Improvement in liver disease severity indice like Model for End-Stage Liver Disease (MELD) score (ΔMELD).
Time frame: 6-month, one year, 2 year and 3 year
Proportion of patients completing treatment without major adverse effects
Time frame: 6-month, one year, 2 year and 3 year
Impact on liver injury (assessed by AST and ALT levels in blood).
Time frame: 6-month, one year, 2 year and 3 year
Impact on fibrosis (evaluated using Masson's Trichome stain and the Enhanced Liver Fibrosis [ELF] score).
Time frame: 6-month, one year, 2 year and 3 year
Impact on regeneration (measured by plasma Alpha-Fetoprotein levels).
Time frame: 6-month, one year, 2 year and 3 year
Impact on bone marrow stem cell reserve (CD34⁺ cell count in peripheral blood)
Time frame: One year, 2 year and 3 year
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 20 Aug 2025.
- 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. Shiv Kumar Sarin, DM principal investigator
Institute of Liver & Biliary Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gcsf, Darbepoetin and Standard Medical Treatment in people with Decompensated 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 1 inclusion and 14 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: opening soon, as of the sponsor's last update on 20 Aug 2025. 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. Anupam Kumar, PhD (01146300000, dr.anupamkumar.ilbs@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transplant-free survival of GCSF + darbepoetin in patients with early decompensated cirrhosis in both groups. (time frame: 3 year). 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 20 Aug 2025.