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G-CSF and Erythropoetin in Survival of Patients With Decompensated Liver Disease

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

Clinical Trial Summary

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)

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01384565
Study type Interventional
Source Institute of Liver and Biliary Sciences, India
Contact
Status Completed
Phase Phase 3
Start date July 2011
Completion date March 2013
View Details
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