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Pegfilgrastim in Patients With Alcoholic Hepatitis

T

Timothy Morgan, MD

Status and phase

Completed
Phase 2

Conditions

Alcoholic Hepatitis

Treatments

Drug: Standard of care
Drug: Standard of care + pegfiltrastim

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02776059
5U01AA021886 (U.S. NIH Grant/Contract)
SCAH Consortium- AH Treatment

Details and patient eligibility

About

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.

Full description

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.

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

34 participants in 2 patient groups

prednisolone or pentoxifylline + pegfiltrastim
Experimental group
Description:
prednisolone or pentoxifylline for 28 days PO plus pegfilgrastim subcutaneous weekly shot
Treatment:
Drug: Standard of care + pegfiltrastim
prednisolone or pentoxifylline
Active Comparator group
Description:
prednisolone or pentoxifylline for 28 days
Treatment:
Drug: Standard of care

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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