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

NCT ID: NCT01036932

Last Updated: 2009-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-08-31

Brief Summary

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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

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Conditions

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Acute on Chronic Liver Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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G-CSF group

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.

Group Type ACTIVE_COMPARATOR

Granulocyte Colony Stimulating Factor

Intervention Type DRUG

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.

Placebo

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

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Govind Ballabh Pant Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Head, Gastroenterology

Principal Investigators

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Shiv K Sarin, MD, DM

Role: PRINCIPAL_INVESTIGATOR

G B Pant Hospital, New Delhi, India

Locations

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Shiv K Sarin

New Delhi, New Delhi, India

Site Status RECRUITING

Countries

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India

Facility Contacts

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Shiv K Sarin, MD, DM

Role: primary

References

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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.

Reference Type DERIVED
PMID: 22119930 (View on PubMed)

Other Identifiers

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IEC MAMC 179

Identifier Type: -

Identifier Source: org_study_id