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

Acute on Chronic Liver Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01036932
• Other study ID #: IEC MAMC 179
• Status: Recruiting
• Phase: N/A
• First received: December 17, 2009
• Last updated: December 18, 2009
• Start date: December 2008
• Est. completion date: August 2010

Study information

• Verified date: December 2009
• Source: Govind Ballabh Pant Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Acute on Chronic Liver Failure
• End Stage Liver Disease
• Liver Failure

Intervention

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.
• 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.

Locations

Country	Name	City	State
India	Shiv K Sarin	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Govind Ballabh Pant Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mobilization of CD34 cells in the peripheral blood		1 month	No
Secondary	clinical/ biochemical improvement in liver function profile		2 months	No
Secondary	frequency of multi-organ failure		2 months	No