Pegfilgrastim in Patients With Alcoholic Hepatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-21

Study Completion Date

2021-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Alcoholic Hepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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prednisolone or pentoxifylline + pegfiltrastim

prednisolone or pentoxifylline for 28 days PO plus pegfilgrastim subcutaneous weekly shot

Group Type EXPERIMENTAL

Standard of care + pegfiltrastim

Intervention Type DRUG

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

prednisolone or pentoxifylline

prednisolone or pentoxifylline for 28 days

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type DRUG

Oral prednisolone or pentoxifyline for 28 days only

Interventions

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Standard of care + pegfiltrastim

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

Intervention Type DRUG

Standard of care

Oral prednisolone or pentoxifyline for 28 days only

Intervention Type DRUG

Other Intervention Names

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Neulasta® prednisolone or pentoxifyline

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No