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

Primary Purpose

Acute on Chronic Liver Failure

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Granulocyte Colony Stimulating Factor
Normal Saline
Sponsored by
Govind Ballabh Pant Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute on Chronic Liver Failure

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shiv K SarinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

G-CSF group

Placebo

Arm Description

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.

After baseline characterization and work up for underlying acute and chronic liver disease, patients were given placebo along with the standard therapy

Outcomes

Primary Outcome Measures

mobilization of CD34 cells in the peripheral blood

Secondary Outcome Measures

clinical/ biochemical improvement in liver function profile
frequency of multi-organ failure

Full Information

First Posted
December 17, 2009
Last Updated
December 18, 2009
Sponsor
Govind Ballabh Pant Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01036932
Brief Title
Granulocyte Colony Stimulating Factor(G-CSF) Therapy for Patients With ACLF
Official Title
To Study the Safety and Efficacy of G-CSF Therapy on the CD 34 Cell Mobilization and Outcome of Patients With ACLF
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2008 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
August 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Govind Ballabh Pant Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute on Chronic Liver Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
G-CSF group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
After baseline characterization and work up for underlying acute and chronic liver disease, patients were given placebo along with the standard therapy
Intervention Type
Drug
Intervention Name(s)
Granulocyte Colony Stimulating Factor
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
mobilization of CD34 cells in the peripheral blood
Time Frame
1 month
Secondary Outcome Measure Information:
Title
clinical/ biochemical improvement in liver function profile
Time Frame
2 months
Title
frequency of multi-organ failure
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiv K Sarin, MD, DM
Organizational Affiliation
G B Pant Hospital, New Delhi, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shiv K Sarin
City
New Delhi
ZIP/Postal Code
110002
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiv K Sarin, MD, DM
Phone
91-11-23234242
Ext
5201
Email
shivsarin@gmail.com
First Name & Middle Initial & Last Name & Degree
Shiv K Sarin, MD, DM

12. IPD Sharing Statement

Citations:
PubMed Identifier
22119930
Citation
Garg V, Garg H, Khan A, Trehanpati N, Kumar A, Sharma BC, Sakhuja P, Sarin SK. Granulocyte colony-stimulating factor mobilizes CD34(+) cells and improves survival of patients with acute-on-chronic liver failure. Gastroenterology. 2012 Mar;142(3):505-512.e1. doi: 10.1053/j.gastro.2011.11.027. Epub 2011 Nov 23.
Results Reference
derived

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

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