Granulocyte Colony Stimulating Factor(G-CSF) Therapy for Patients With ACLF

Not Applicable

• Conditions: Acute on Chronic Liver Failure
• Interventions: Drug: Normal Saline; Drug: Granulocyte Colony Stimulating Factor

• Registration Number: NCT01036932
• Lead Sponsor: Govind Ballabh Pant Hospital

Brief Summary

The purpose of the study is to determine whether Granulocyte Colony Stimulating factor(G-CSF) therapy is effective in the treatment of patients with Acute on chronic liver failure(ACLF). The investigators hypothesize that ACLF is a disease where severe hepatic impairment is accompanied by impaired hepatic regeneration. BMC mobilization using G-CSF therapy, or G-CSF therapy per se would increase the regenerative capacity of the liver and shall lead to clinical, biochemical and histological improvements in patients with ACLF.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Status Verified: 2009-12
• Study First Submitted: 2009-12-17
• Study First Submitted QC: 2009-12-18
• Last Update Submitted: 2009-12-18
• Study First Posted: 2009-12-21
• Last Update Posted: 2009-12-21
• Primary Completion: 2010-08
• Study Completion: 2010-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients with acute hepatic insult manifesting as jaundice (Sr. Bil. ≥5 mg/dL) and coagulopathy (INR≥1.5), complicated within 4 weeks by ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease.(APASL criteria)

Exclusion Criteria

• HCC or portal vein thrombosis. Refusal to participate in the study. Sepsis ( Any culture positive: blood, urine, focus of infection on Xray chest, any other obvious source of infection: UTI, SBP) Multi organ failure. Grade 3 or 4 hepatic encephalopathy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Normal Saline	After baseline characterization and work up for underlying acute and chronic liver disease, patients were given placebo along with the standard therapy
G-CSF group	Granulocyte Colony Stimulating Factor	Patients with Acute on chronic liver failure after baseline investigations for the etiology of the acute event and the underlying chronic disease were given Granulocyte Colony Stimulating Factor therapy for a total duration of one month.

Primary Outcome Measures

Name	Time	Method
mobilization of CD34 cells in the peripheral blood	1 month

Secondary Outcome Measures

Name	Time	Method
clinical/ biochemical improvement in liver function profile	2 months
frequency of multi-organ failure	2 months

Trial Locations

Locations (1)

Shiv K Sarin; 🇮🇳 New Delhi, India