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CompletedNCT02451033Updated Aug 29, 2017

Granulocyte Colony Stimulating Factor And Growth Hormone In Cirrhosis Of Liver: An Open Label Study

A Phase 2/3 interventional study of standard medical therapy and G-CSF in Cirrhosis, sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Completed at 2 sites in India. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-08-29.

Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study summary

Cirrhosis of liver is a leading cause of morbidity and mortality worldwide . Complications including ascites, spontaneous bacterial peritonitis (SBP), variceal bleed, hepatic encephalopathy, hepatorenal syndrome (HRS) and development of hepatocellular carcinoma (HCC) have poor prognosis and further decreases the survival in these patients. It has been believed that cirrhosis is irreversible and that treatment should focus on preventing the progression of liver fibrosis/dysfunction and its complications.

Currently the only effective treatment is liver transplantation, an increasingly limited and expensive resource especially in developing countries. Furthermore, transplantation comes with a requirement for lifelong immunosuppression, and considerable long-term side effects that include chronic renal failure, post-transplant lymphoproliferative disease, and cardiovascular complications.

Short of liver transplant, recently, reports of unexpected plasticity in adult bone marrow have raised hopes that stem cell therapy may offer exciting therapeutic possibilities for patients with end stage liver diseases. It has been shown that in response to acute or chronic liver damage, bone marrow derived stem cells can spontaneously populate the liver and differentiate into hepatic cells. Animal and human studies suggested that such cells might contribute to the regeneration after different kinds of liver injuries . In animal models, after liver injury, bone marrow-derived circulating pluripotent cells have been reported to participate in liver repopulation with both non-parenchymal cells and hepatocytes. This repopulation process, however, seems to be highly dependent on the type of liver injury and experimental conditions. Fusion with hematopoietic cells has been substantiated as a mechanism by which hepatocytes can regenerate, and studies have demonstrated improved liver histology and survival in patients with cirrhosis following mobilization of bone marrow stem cells by granulocyte-colony stimulating factor (G-CSF) . Three recent studies have demonstrated G-CSF induced mobilization of bone marrow stem cells (CD34 cells) in peripheral blood and their subsequent increase in liver tissue and improved survival in patients with alcoholic hepatitis and acute on chronic liver failure (ACLF) . However there is insufficient data on whether G-CSF improves survival and prognosis in patients with cirrhosis.

Also, Malnutrition is commonly seen (60-70%) in cirrhotics and have adverse prognosis on its outcome . The protein catabolic state of cirrhosis is associated with severe growth hormone (GH) resistance, with low levels of insulin-like growth factor (IGF)-I and its major binding protein (IGFBP)-3 . GH therapy in cirrhosis have been shown to improve nitrogen economy and to improve the GH resistance in a small pilot study. Also, GH therapy of short duration has shown to increase IGF1 levels, IGFBP-3 levels in patients of cirrhosis . GH therapy has also shown to improve liver regeneration and protein synthesis after hepatectomy in patients of HCC with cirrhosis . However there is scarcity of data on clinical impact of long term administration of GH therapy in patients of cirrhosis.

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Conditions studied

  • Cirrhosis

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Keywords

  • Regenerative medicine
03

In context

Fibrosis

3,274 studies on the registry are indexed under Fibrosis; 466 are open to participants now.

This study's enrollment of 65 is above the median of 50 across 2,137 interventional studies indexed under Fibrosis.

Browse Fibrosis studies →

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh is the lead sponsor of 296 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Decompensated Cirrhosis of liver.

Exclusion criteria

Exclusion Criteria:

  • Acute on chronic liver failure
  • Spleen diameter of larger than 180 mm
  • Diagnosis of concomitant hepatocellular carcinoma or other active malignancy
  • Upper gastrointestinal bleed due to portal hypertension in the previous 7 days
  • Recent episode of portal vein thrombosis
  • Severe renal dysfunction creatinine (>1.5mg/dl)
  • Severe cardiac dysfunction
  • Uncontrolled diabetes or diabetic retinopathy
  • Acute infection or disseminate intravascular coagulation
  • Active alcohol abuse in last 3months
  • Known hypersensitivity to G-CSF and GH
  • Human immunodeficiency virus seropositivity
  • Pregnancy
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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
65 participants (actual)

Study arms

  • Active comparator
    standard medical therapy

    Standard medical therapy

    Drug: standard medical therapy

  • Active comparator
    G-CSF

    Standard medical therapy plus G-CSF at the dosage of 5 µg/Kg subcutaneously every 12 hr for five consecutive days then every 3 monthly for 3 days till 1 year.

    Drug: standard medical therapy · Drug: G-CSF

  • Active comparator
    G-CSF plus growth hormone

    Standard medical therapy plus G-CSF plus Growth Hormone therapy. Growth Hormone will be given in low dose of 1unit sc daily for 1 year.

    Drug: standard medical therapy · Drug: G-CSF · Drug: Growth Hormone

Interventions

  • Drugstandard medical therapy

    diuretics, albumin infusion, antibiotics, nutrition, and variceal banding wherever needed

  • DrugG-CSF

    Drug pages: Granulocyte Colony-Stimulating Factor · Filgrastim

    G-CSF at the dosage of 5 µg/Kg subcutaneously every 12 hr for five consecutive days then every 3 monthly for 3 days till 1 year

  • Growth Hormone in low dose of 1unit sc daily for 1 year

06

What researchers measure

Primary outcomes

  1. Transplant free survival

    Survival at 1 year from the onset of therapy

    Time frame: 1 year

Secondary outcomes

  1. haematopoietic stem cell mobilization

    Mobilisation of CD34+ cells in peripheral blood

    Time frame: 1 year

  2. safety as measured by adverse effects of G-CSF, GH and combination in cirrhosis of liver

    Adverse effects of G-CSF, GH and combination in cirrhosis of liver

    Time frame: 1 year

  3. Clinical/biochemical improvement in liver function profile

    Improvement in prognostic scores - MELD score, and Child score

    Time frame: 1 year

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Study locations

2 sites
  • Dept. of Hepatology, PGIMER, Chandigarh
    Chandigarh, 160012, India
  • Department of Hepatology,Postgraduate Institute of Medical Education and Research
    Chandigarh, India
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References and documents

Publications

  • Kaur A, Verma N, Singh B, Kumar A, Kumari S, De A, Sharma RR, Singh V. Quantitative liver SPECT/CT is a novel tool to assess liver function, prognosis, and response to treatment in cirrhosis. Front Med (Lausanne). 2023 Mar 22;10:1118531. doi: 10.3389/fmed.2023.1118531. eCollection 2023. PubMed 37035316 ↗
  • Verma N, Kaur A, Sharma R, Bhalla A, Sharma N, De A, Singh V. Outcomes after multiple courses of granulocyte colony-stimulating factor and growth hormone in decompensated cirrhosis: A randomized trial. Hepatology. 2018 Oct;68(4):1559-1573. doi: 10.1002/hep.29763. Epub 2018 Jul 25. PubMed 29278428 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2015 to primary completion in Jun 2016, 13 months.

Of 18 phase 2/3 interventional studies under Fibrosis, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's 13 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 12, 2015
First posted
May 21, 2015
StartActual
May 2015
Primary completionActual
Jun 2016
CompletionActual
Jun 2016
Last update
Aug 29, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02451033
Responsible party
Dr.Virendra Singh (Professor of Hepatology, Post Graduate Institute of Medical Education and Research, Chandigarh) — Principal investigator
First posted
May 21, 2015
Start date
May 2015
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Aug 29, 2017

Study contacts

Virendra Singh, MD;DM
principal investigator · Professor of Hepatology,PGIMER,Chandigarh

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Granulocyte Colony-Stimulating Factor · Filgrastim · Growth Hormone

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