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Pegfilgrastim in Patients With Alcoholic Hepatitis

NCT02776059 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2021-09-29

No results posted yet for this study

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.

Conditions

  • Alcoholic Hepatitis

Interventions

DRUG

Standard of care + pegfiltrastim

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

DRUG

Standard of care

Oral prednisolone or pentoxifyline for 28 days only

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Timothy Morgan, MD

    lead OTHER

Principal Investigators

  • Timothy Morgan, MD · VA Long Beach Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-21
Primary Completion
2020-03-31
Completion
2021-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02776059 on ClinicalTrials.gov