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

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Decompensated Cirrhosis

Treatments: Drug: G-CSF+Erythropoetin; Drug: G-CSF

Study type: Interventional

Funder types: Other

Identifiers

NCT01902511

ILBS-Hepatic Regeneration -001

Details and patient eligibility

About

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).

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

G-CSF + Erythropoietin

Experimental group

Treatment:

Drug: G-CSF

G-CSF

Active Comparator group

Treatment:

Drug: G-CSF+Erythropoetin