Trial intelligence / Profile preview

G-CSF in Decompensated Cirrhosis

NCT03911037Phase 3

Key facts

Status: Unknown
Start: May 2019
Primary completion: Jun 2020
Countries: 1
Sponsor: Post Graduate Institute of Medical Education and Research
Modality: Cytokines & Interferons

Drugs: filgrastim
Conditions: decompensated cirrhosis

Overview

Phase 3, randomised, double-blind trial in decompensated cirrhosis comparing G-CSF Arm with Placebo Arm (2 arms). Primary endpoint: Overall Survival at 1 year. Status: unknown.

Design

2 arms

Study design: RandomizedDouble-blind

G-CSF Arm
G-CSF 5 mcg/kg SC q12h for 5 days, repeated every 3 months for 4 cycles + SMT
Placebo Arm
Placebo SC q12h for 5 days, repeated every 3 months for 4 cycles + SMT

Who it enrols

Patients with decompensated cirrhosis of any etiology, excluding those with ACLF, large spleen (>18cm), HCC, recent GI bleed, severe renal/cardiac dysfunction, uncontrolled diabetes, active infection, active alcohol abuse, or HIV.

Endpoints

Primary

Overall Survival1 year

Secondary

Hemopoietic stem cell mobilisation1 year
Clinical improvement in liver functions1 year
Biochemical improvement in liver functions1 year
Improvement in nutritional status1 year
Improvement in quality of life1 year
Depression1 year
Demoralisation scale1 year
Immunological profile1 year

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