Chronic Liver Disease Clinical Trial
Official title:
A Prospective Randomized Double Blind Trial to Study the Efficacy of G-CSF and Erythropoetin in Survival of Patients With Decompensated Liver Disease
Verified date | July 2012 |
Source | Institute of Liver and Biliary Sciences, India |
Contact | n/a |
Is FDA regulated | No |
Health authority | India: Ministry of Health |
Study type | Interventional |
Study Design
50 patients will be enrolled and randomized into patients (Group IA) and controls (Group I
B)
Investigations:
Hematology CBC, Prothrombin time and INR Peripheral smear, Retics Biochemistry Liver
function testing, AFP Kidney function testing Etiology of chronic liver disease Infectious
etiology: total antiHBc, anti HCV, HCV RNA, HBV DNA Non infectious etiology: Autoimmune
markers, copper studies, iron studies, HOMA IR, FBS Etiology of decompensation Variceal
bleed Infection ( blood culture, urine culture, sputum culture, chest xray) Surgery Drugs
Alcohol intake Ascitic fluid analysis UGI endoscopy Imaging USG abdomen with Doppler for
spleno-portal axis CECT- Triple phase upper abdomen Liver regenerative potential efficacy
testing Histology ( by transjugular liver biopsy) Liver Dendritic cells ( CD11c, CD40, CD
54, CD 123, BDCA 2 staining) by flow cytometry CD 34+ cells, CD 45+ cells and CD 133+ cells
measurement in hepatic venous blood, peripheral blood and liver biopsy by flow cytometry
Markers of proliferation like Ki- 67, proliferating cell nuclear antigen (PCNA) in liver
biopsy Markers of angiogenesis like VEGF, v WF in hepatic venous blood Measurement of
Hepatic venous pressure gradient ( HVPG)
Status | Completed |
Enrollment | 55 |
Est. completion date | March 2013 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years to 75 Years |
Eligibility |
Inclusion Criteria: - All patients who were known to have cirrhosis of liver with portal hypertension, now decompensated with ascites/ jaundice/ bleed/ HE/ HRS Exclusion Criteria: - Age <12 or > 75 years - Autoimmune disorders - HCC - Sepsis ( Any culture positive: blood, urine, any other obvious source of infection: UTI, SBP) - Multi organ failure - Grade 4 HE - HIV seropositivity / pregnancy - Essential Hypertension - Patients being taken up for transplant - Refusal to participate in the study |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | Institute of liver and Biliary Sciences | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
Institute of Liver and Biliary Sciences, India |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | transplant free survival at 1 year | 3 Months | No | |
Secondary | transplant free survival at 6 months, histo-pathological evidence of hepatic regeneration and mobilization of CD34/stem cells, improvement in severity assessment indices | 6 Months | No |
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