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CirrhosisPhase 2/3NCT02451033

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

A Phase 2/3 study testing standard medical therapy, G-CSF and Growth Hormone in people with Cirrhosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 2 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cirrhosis
What is being tested?
standard medical therapy, G-CSF and Growth Hormone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
2 sitesIndia
Study dates
May 2015to Jun 2016
Phase
Phase 2/3
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Decompensated Cirrhosis of liver.

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

2 sites in 1 country.

India2 sites
  • Dept. of Hepatology, PGIMER, Chandigarh

    Chandigarh, 160012

  • Department of Hepatology,Postgraduate Institute of Medical Education and Research

    Chandigarh

Other trials in India

About this study

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.

Read more

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.

Conditions
Cirrhosis
Being tested
standard medical therapy, G-CSF, Growth Hormone
Keywords
Regenerative medicine
Medical subject headings
Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • standard medical therapyDrug

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

  • G-CSFDrug

    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 HormoneDrug

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

Study groups in NCT02451033
Study groupRoleWhat they receive
standard medical therapyActive comparatorStandard medical therapy
Receives: Drug: standard medical therapy
G-CSFActive comparatorStandard 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.
Receives: Drug: standard medical therapy; Drug: G-CSF
G-CSF plus growth hormoneActive comparatorStandard medical therapy plus G-CSF plus Growth Hormone therapy. Growth Hormone will be given in low dose of 1unit sc daily for 1 year.
Receives: Drug: standard medical therapy; Drug: G-CSF; Drug: Growth Hormone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Transplant free survival

    Survival at 1 year from the onset of therapy

    Measured: 1 year

Secondary outcomes (3)
  1. haematopoietic stem cell mobilization

    Mobilisation of CD34+ cells in peripheral blood

    Measured: 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

    Measured: 1 year

  3. Clinical/biochemical improvement in liver function profile

    Improvement in prognostic scores - MELD score, and Child score

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02451033
Sponsor's protocol ID
G-CSF and GH in cirrhosis
Status last verified
Aug 2017
First submitted
12 May 2015
Last updated
29 Aug 2017
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing standard medical therapy, G-CSF and Growth Hormone in people with Cirrhosis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 2 sites 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 13 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 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Transplant free survival (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 NCT02451033, 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 29 Aug 2017.

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