Pegfilgrastim in Patients With Alcoholic Hepatitis

• Status: Completed
• Trial end date: 2021-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Timothy Morgan, MD
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Pentoxifylline; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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.