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

NCT01036932 | Unknown DMC

• 1 other identifier: IEC MAMC 179
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute on Chronic Liver Failure

Outcome Measures

Primary Outcomes (1)

• mobilization of CD34 cells in the peripheral blood

  1 month

Secondary Outcomes (2)

• clinical/ biochemical improvement in liver function profile

  2 months

• frequency of multi-organ failure

  2 months

Study Arms (2)

G-CSF group

ACTIVE COMPARATOR

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.

Drug: Granulocyte Colony Stimulating Factor

Placebo

PLACEBO COMPARATOR

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

Drug: Normal Saline

Interventions

Granulocyte Colony Stimulating Factor 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.

G-CSF group

Normal Saline 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.

Placebo

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Govind Ballabh Pant Hospital: lead

Study Sites (1)

Shiv K Sarin

New Delhi, New Delhi, 110002, India

RECRUITING

Related Publications (1)

• 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.

  PMID: 22119930 DERIVED

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Interventions

Granulocyte Colony-Stimulating Factor; Saline Solution

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Shiv K Sarin, MD, DM

  G B Pant Hospital, New Delhi, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: December 17, 2009
• First Posted: December 21, 2009
• Study Start: December 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: December 21, 2009

Record last verified: 2009-12

Locations

IN (1)