Pegfilgrastim in Patients With Alcoholic Hepatitis

Timothy Morgan, MD34 enrolled

Overview

This is a multi-center, prospective, randomized trial of standard of care vs. standard of care + pegfilgrastim (Neulasta®) among patients with a clinical diagnosis of alcoholic hepatitis and DF≥32.

Standard of care treatment will be with either prednisolone 40 mg/day for 28 days or pentoxifylline 400 mg TID for 28 days. The patient's physician will decide the standard of care treatment the patient will receive. Patients will be randomized (1:1) to receive either no additional drug treatment (SOC group) or to receive a pegfilgrastim (Neulasta®, 6 mg) SQ. Patients will be seen in-person at screening, randomization (Day 1), Day 8, Day 29, Week 12, and Week 24. Safety examination and blood tests will be performed. In addition, biological specimens will be saved for research purposes at these time points. Total duration of patient participation is 24 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alcoholic Hepatitis

Interventions

Standard of care + pegfiltrastimDRUG

prednisolone or pentoxifyline orally for 28 days + pegfilgrastim (Neulasta®) 6 mg in 0.6 mL SQ

Standard of careDRUG

Oral prednisolone or pentoxifyline for 28 days only

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A clinical diagnosis of alcoholic hepatitis with Maddrey's discriminant function score ≥32. Age 18 years or older. Exclusion Criteria: * Renal failure (creatinine \>2.0 mg/dl) * Bilirubin \<5 mg/dL * uncontrolled recent upper gastrointestinal bleeding * Known HIV infection * Uncontrolled infection, or pregnant.

Locations (5)

VA Loma Linda Healthcare System

Loma Linda, California, United States

VA Long Beach Healthcare System

Long Beach, California, United States

LAC-USC Medical Center

Los Angeles, California, United States

Harbor-UCLA Medical Center

Torrance, California, United States

Outcomes

Primary Outcomes

Adverse events, especially infection and renal failure, Change in MELD Score and DF between Day 1 and Day 29, Lille score (at Day 8)

The primary outcome will be survival at Day 90. Assuming a fixed sample size of 70 patients (35 per arm), a one-sided z-test will have 81.6% power to detect a 25% improvement in survival proportions between arms, with survival in the standard of care arm at 65%.

Time frame: Day 1, Day 8, Day 29, and Day 90

Secondary Outcomes

adverse events

adverse events through Week 24

Time frame: 24 weeks

Liver function

Change in MELD and Maddrey DF during first 4 weeks

Time frame: Day 29

liver function

Change in Lille score

Time frame: Day 8

Survival

survival at Day 90

Time frame: at Day 90

Data from ClinicalTrials.gov

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