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A Trial to Study the Influence of Growth Factors on Bone Marrow and Hepatic Regeneration in Patients With Decompensated Cirrhosis.

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ClinicalTrials.gov Identifier: NCT01902511
Recruitment Status : Completed
First Posted : July 18, 2013
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Brief 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.

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).


Condition or disease Intervention/treatment Phase
Decompensated Cirrhosis Drug: G-CSF+Erythropoetin Drug: G-CSF Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : July 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
Experimental: G-CSF + Erythropoietin Drug: G-CSF
Active Comparator: G-CSF Drug: G-CSF+Erythropoetin



Primary Outcome Measures :
  1. The primary end point will be transplant free survival rate at 1 year in patients with decompensated cirrhosis. [ Time Frame: 1 Year ]

Secondary Outcome Measures :
  1. Histopathological evidence of hepatic regeneration and mobilization of CD34/stem cells [ Time Frame: 1 Year ]
  2. 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 ]
  3. Development of new complications such as appearance or worsening of hepatic encephalopathy, hepatorenal syndrome and sepsis. [ Time Frame: 1 Year ]
  4. 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 ]
  5. Transplant free survival at 6 months in both groups [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • HIV seropositivity
  • Essential hypertension
  • Pregnancy
  • Refusal to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902511


Locations
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India
Institute of Liver & Biliary Sciences
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
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Principal Investigator: Dr Lovkesh Anand, MD Institute of Liver & Biliary Sciences.

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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT01902511     History of Changes
Other Study ID Numbers: ILBS-Hepatic Regeneration -001
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
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Liver Cirrhosis
Pathologic Processes
Liver Diseases
Fibrosis
Digestive System Diseases
Lenograstim
Epoetin Alfa
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Hematinics