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Completed

NCT Number: NCT01902511

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

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).

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Key information

Conditions

Decompensated Cirrhosis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

G-CSF+Erythropoetin

Drug

G-CSF

Drug

Primary outcomes

  1. The primary end point will be transplant free survival rate at 1 year in patients with decompensated cirrhosis.

    Time frame: 1 Year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 18, 2013
Registry last updated
Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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