Pegfilgrastim in Patients With Alcoholic Hepatitis

September 23, 2021 updated by: Timothy Morgan, MD

A Phase II, Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of Pegfilgrastim (Neulasta®) in Patients With Alcoholic Hepatitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92357
        • VA Loma Linda Healthcare System
      • Long Beach, California, United States, 98022
        • VA Long Beach Healthcare System
      • Los Angeles, California, United States, 90089
        • LAC-USC Medical Center
      • Torrance, California, United States, 90502
        • Harbor-UCLA Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • New Mexico VA Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: prednisolone or pentoxifylline + pegfiltrastim
prednisolone or pentoxifylline for 28 days PO plus pegfilgrastim subcutaneous weekly shot
Drug: Standard of care + pegfiltrastim
prednisolone or pentoxifyline orally for 28 days + pegfilgrastim (Neulasta®) 6 mg in 0.6 mL SQ
Other Names:
  • Neulasta®
ACTIVE_COMPARATOR: prednisolone or pentoxifylline
prednisolone or pentoxifylline for 28 days
Drug: Standard of care
Oral prednisolone or pentoxifyline for 28 days only
Other Names:
  • prednisolone or pentoxifyline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events, especially infection and renal failure, Change in MELD Score and DF between Day 1 and Day 29, Lille score (at Day 8)
Time Frame: Day 1, Day 8, Day 29, and Day 90
The primary outcome will be survival at Day 90. Assuming a fixed sample size of 70 patients (35 per arm), a one-sided z-test will have 81.6% power to detect a 25% improvement in survival proportions between arms, with survival in the standard of care arm at 65%.
Day 1, Day 8, Day 29, and Day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events
Time Frame: 24 weeks
adverse events through Week 24
24 weeks
Liver function
Time Frame: Day 29
Change in MELD and Maddrey DF during first 4 weeks
Day 29
liver function
Time Frame: Day 8
Change in Lille score
Day 8
Survival
Time Frame: at Day 90
survival at Day 90
at Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Timothy Morgan, MD

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Study Chair: Timothy Morgan, MD, VA Long Beach Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 21, 2017

Primary Completion (ACTUAL)

March 31, 2020

Study Completion (ACTUAL)

March 31, 2021

Study Registration Dates

First Submitted

May 10, 2016

First Submitted That Met QC Criteria

May 15, 2016

First Posted (ESTIMATE)

May 18, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 23, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCAH Consortium- AH Treatment
  • 5U01AA021886 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patients' coded data will be shared .

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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