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

Govind Ballabh Pant Hospital

Status: Unknown

Conditions: Acute on Chronic Liver Failure

Treatments: Drug: Granulocyte Colony Stimulating Factor; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01036932

IEC MAMC 179

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

G-CSF group

Active Comparator group

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.

Treatment:

Drug: Granulocyte Colony Stimulating Factor

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal Saline