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

Decompensated Cirrhosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01902511
• Other study ID #: ILBS-Hepatic Regeneration -001
• Status: Completed
• Phase: N/A
• First received: July 15, 2013
• Last updated: November 21, 2016
• Start date: July 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Decompensated Cirrhosis
• Fibrosis
• Liver Cirrhosis

Intervention

Drug:
• G-CSF+Erythropoetin

• G-CSF

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary end point will be transplant free survival rate at 1 year in patients with decompensated cirrhosis.		1 Year	Yes
Secondary	Histopathological evidence of hepatic regeneration and mobilization of CD34/stem cells		1 Year	No
Secondary	Histopathological evidence of contribution of bone marrow precursor cells in hepatic regeneration and the markers predicting positive response to growth factors		1 Year	No
Secondary	Development of new complications such as appearance or worsening of hepatic encephalopathy, hepatorenal syndrome and sepsis.		1 Year	No
Secondary	Improvement in severity assessment scores and safety profile of G-CSF (Growth-Colony Stimulating Factor) + EPO (Erythropoetin)dual therapy vs. G-CSF alone.		1 Year	No
Secondary	Transplant free survival at 6 months in both groups		6 months	No