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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01036932
Other study ID # IEC MAMC 179
Secondary ID
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


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
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