Pegfilgrastim in Patients With Alcoholic Hepatitis

Completed · Phase 2

Conditions studied: Alcoholic Hepatitis

In brief

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.

Key facts

Study ID

NCT02776059

Run by

Timothy Morgan, MD

People needed

34

Starts

2017-01-21

Expected to finish

2021-03-31

Last updated by the study team

2021-09-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A clinical diagnosis of alcoholic hepatitis with Maddrey's discriminant function score ≥32. Age 18 years or older.

You may not qualify if…

• Renal failure (creatinine >2.0 mg/dl)
• Bilirubin <5 mg/dL
• uncontrolled recent upper gastrointestinal bleeding
• Known HIV infection
• Uncontrolled infection, or pregnant.

Where it is running

• 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
• New Mexico VA Health Care System — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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