NCT01036932

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

To Study the Safety and Efficacy of G-CSF Therapy on the CD 34 Cell Mobilization and Outcome of Patients With ACLF

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Govind Ballabh Pant Hospital · Other Government
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute on Chronic Liver Failure

Interventions

Type	Name	Description
DRUG	Granulocyte Colony Stimulating Factor	Dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5, and then every 3rd day till day 28 (total 12 doses) along with the standard therapy.
DRUG	Normal Saline	dose of 1ml s/c at days 1, 2, 3, 4, 5, and then every 3rd day till day 28 (total 12 doses) along with the standard therapy.

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2009-12-21
• Last updated: 2009-12-21

Locations

1 site across 1 country: India