Decompensated Cirrhosis Clinical Trial
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).
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | Institute of Liver & Biliary Sciences | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
Institute of Liver and Biliary Sciences, India |
India,
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 |
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