Decompensated CirrhosisNCT01902511
A Trial to Study the Influence of Growth Factors on Bone Marrow and Hepatic Regeneration in Patients With Decompensated Cirrhosis.
A study testing G-CSF+Erythropoetin and G-CSF in people with Decompensated Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
This will be a randomized double blind study which will be conducted on patients admitted to Department of Hepatology from June 2013 to may 2014 at ILBS, New Delhi. Patients not having any exclusion criteria will undergo bone marrow examination and liver biopsy at the baseline. 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?
- G-CSF+Erythropoetin and G-CSF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subjects aged 18-65 years
- All patients who are known to have cirrhosis of liver with portal hypertension and are compensated on presentation with no features of ascites/ jaundice/ bleed/ HE/ HRS.
- Only patients with alcoholic cirrhosis and cryptogenic cirrhosis (etiology work up negative) will be enrolled in the study.
Who cannot join
- Sepsis ( Any culture positive: blood, urine, any other obvious source of infection: UTI, LRTI)
- Variceal bleed in the past 3 months
- Autoimmune disorders
- HCC (Hepatocellular Carcinoma)
- Multi organ failure
- Any features of decompensation in form of ascites/Jaundice/ HE (grade 3 or 4) / HRS
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- HIV seropositivity
- Essential hypertension
- Pregnancy
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
This will be a randomized double blind study which will be conducted on patients admitted to Department of Hepatology from June 2013 to may 2014 at ILBS, New Delhi. Patients not having any exclusion criteria will undergo bone marrow examination and liver biopsy at the baseline.
60 patients of decompensated cirrhosis will be randomised into two limbs- limb A (30 patients) will receive G-CSF and erythropoietin while those on limb B (30 patients) will receive G-CSF alone. The drugs will be given for 2 months and patient will be followed for 1 year. G-CSF will be given at a dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 60 (total 22 doses). Erythropoietin will be given s/c at dose of 500 IU/Kg twice a week for 2 months.
Follow up will be done on days 0,3,7,14,28, day 42 (6 weeks), day 60 (2 months), day 90 (3 months), day 180 (6 months), day 270 (9 months); and day 360 (1 year).
- Conditions
- Decompensated Cirrhosis
- Being tested
- G-CSF+Erythropoetin, G-CSF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-CSF+ErythropoetinDrug
G-CSFDrug
| Study group | Role | What they receive |
|---|---|---|
| G-CSF + Erythropoietin | Experimental | Not described Receives: Drug: G-CSF |
| G-CSF | Active comparator | Not described Receives: Drug: G-CSF+Erythropoetin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point will be transplant free survival rate at 1 year in patients with decompensated cirrhosis.
Measured: 1 Year
Secondary outcomes (5)
Histopathological evidence of hepatic regeneration and mobilization of CD34/stem cells
Measured: 1 Year
Histopathological evidence of contribution of bone marrow precursor cells in hepatic regeneration and the markers predicting positive response to growth factors
Measured: 1 Year
Development of new complications such as appearance or worsening of hepatic encephalopathy, hepatorenal syndrome and sepsis.
Measured: 1 Year
Improvement in severity assessment scores and safety profile of G-CSF (Growth-Colony Stimulating Factor) + EPO (Erythropoetin)dual therapy vs. G-CSF alone.
Measured: 1 Year
Transplant free survival at 6 months in both groups
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 posted18 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Decompensated CirrhosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Lovkesh Anand, MD, Principal investigator, Institute of Liver & Biliary Sciences.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902511
- Sponsor's protocol ID
- ILBS-Hepatic Regeneration -001
- Status last verified
- Feb 2016
- First submitted
- 15 Jul 2013
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kumar D, Maheshwari D, Nautiyal N, Shubham S, Rooge S, Anand L, Vyas A, Kumari R, Sharma S, Bihari C, Mohanty S, Maiwall R, Kumar A, Sarin SK. Defects in energy metabolism are associated with functional exhaustion of bone marrow mesenchymal stem cells in cirrhosis. Am J Stem Cells. 2022 Feb 15;11(1):12-27. eCollection 2022.
PubMed 35295591Anand L, Bihari C, Kedarisetty CK, Rooge SB, Kumar D, Shubham S, Kumar G, Sahney A, Sharma MK, Maiwall R, Kumar A, Sarin SK. Early cirrhosis and a preserved bone marrow niche favour regenerative response to growth factors in decompensated cirrhosis. Liver Int. 2019 Jan;39(1):115-126. doi: 10.1111/liv.13923. Epub 2018 Aug 10.
PubMed 29962032
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Study the Influence of Growth Factors on Bone Marrow and Hepatic Regeneration in Patients With Decompensated Cirrhosis.
- ClinicalTrials.gov ID
- NCT01902511
- Acronym / sponsor ID
- ILBS-Hepatic Regeneration -001
- Conditions
- Decompensated Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Jul 2013 (estimated)
- 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.
This will be a randomized double blind study which will be conducted on patients admitted to Department of Hepatology from June 2013 to may 2014 at ILBS, New Delhi. Patients not having any exclusion criteria will undergo bone marrow examination and liver biopsy at the baseline.
60 patients of decompensated cirrhosis will be randomised into two limbs- limb A (30 patients) will receive G-CSF and erythropoietin while those on limb B (30 patients) will receive G-CSF alone. The drugs will be given for 2 months and patient will be followed for 1 year. G-CSF will be given at a dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 60 (total 22 doses). Erythropoietin will be given s/c at dose of 500 IU/Kg twice a week for 2 months.
Follow up will be done on days 0,3,7,14,28, day 42 (6 weeks), day 60 (2 months), day 90 (3 months), day 180 (6 months), day 270 (9 months); and day 360 (1 year).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G-CSF + Erythropoietin | Experimental | Drug: G-CSF |
| G-CSF | Active comparator | Drug: G-CSF+Erythropoetin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects aged 18-65 years
- All patients who are known to have cirrhosis of liver with portal hypertension and are compensated on presentation with no features of ascites/ jaundice/ bleed/ HE/ HRS.
- Only patients with alcoholic cirrhosis and cryptogenic cirrhosis (etiology work up negative) will be enrolled in the study.
Key exclusion criteria (10 listed)
- Sepsis ( Any culture positive: blood, urine, any other obvious source of infection: UTI, LRTI)
- Variceal bleed in the past 3 months
- Autoimmune disorders
- HCC (Hepatocellular Carcinoma)
- Multi organ failure
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 |
|---|---|---|
| G-CSF+Erythropoetin | Drug | G-CSF |
| G-CSF | Drug | G-CSF + Erythropoietin |
Primary outcome
The primary end point will be transplant free survival rate at 1 year in patients with decompensated cirrhosis.
Time frame: 1 Year
5 secondary outcomes
Histopathological evidence of hepatic regeneration and mobilization of CD34/stem cells
Time frame: 1 Year
Histopathological evidence of contribution of bone marrow precursor cells in hepatic regeneration and the markers predicting positive response to growth factors
Time frame: 1 Year
Development of new complications such as appearance or worsening of hepatic encephalopathy, hepatorenal syndrome and sepsis.
Time frame: 1 Year
Improvement in severity assessment scores and safety profile of G-CSF (Growth-Colony Stimulating Factor) + EPO (Erythropoetin)dual therapy vs. G-CSF alone.
Time frame: 1 Year
Transplant free survival at 6 months in both groups
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- Derived from this study: PubMed 35295591Kumar D, Maheshwari D, Nautiyal N, Shubham S, Rooge S, Anand L, Vyas A, Kumari R, Sharma S, Bihari C, Mohanty S, Maiwall R, Kumar A, Sarin SK. Defects in energy metabolism are associated with functional exhaustion of bone marrow mesenchymal stem cells in cirrhosis. Am J Stem Cells. 2022 Feb 15;11(1):12-27. eCollection 2022.
- Derived from this study: PubMed 29962032Anand L, Bihari C, Kedarisetty CK, Rooge SB, Kumar D, Shubham S, Kumar G, Sahney A, Sharma MK, Maiwall R, Kumar A, Sarin SK. Early cirrhosis and a preserved bone marrow niche favour regenerative response to growth factors in decompensated cirrhosis. Liver Int. 2019 Jan;39(1):115-126. doi: 10.1111/liv.13923. Epub 2018 Aug 10.
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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. This study is not recruiting at the moment.
Dr Lovkesh Anand, MD 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 G-CSF+Erythropoetin and G-CSF 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 22 Nov 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end point will be transplant free survival rate at 1 year in patients with decompensated cirrhosis. (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01902511, which also lists 2 linked publications.
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 Nov 2016.