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Pegfilgrastim in Patients With Alcoholic Hepatitis

Primary Purpose

Alcoholic Hepatitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Standard of care + pegfiltrastim
Standard of care
Sponsored by
Timothy Morgan, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholic Hepatitis focused on measuring survival, pegfilgrastim, cirrhosis, alcoholic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • VA Loma Linda Healthcare System
  • VA Long Beach Healthcare System
  • LAC-USC Medical Center
  • Harbor-UCLA Medical Center
  • New Mexico VA Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

prednisolone or pentoxifylline + pegfiltrastim

prednisolone or pentoxifylline

Arm Description

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

prednisolone or pentoxifylline for 28 days

Outcomes

Primary Outcome Measures

Adverse events, especially infection and renal failure, Change in MELD Score and DF between Day 1 and Day 29, Lille score (at Day 8)
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%.

Secondary Outcome Measures

adverse events
adverse events through Week 24
Liver function
Change in MELD and Maddrey DF during first 4 weeks
liver function
Change in Lille score
Survival
survival at Day 90

Full Information

First Posted
May 10, 2016
Last Updated
September 23, 2021
Sponsor
Timothy Morgan, MD
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT02776059
Brief Title
Pegfilgrastim in Patients With Alcoholic Hepatitis
Official Title
A Phase II, Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of Pegfilgrastim (Neulasta®) in Patients With Alcoholic Hepatitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 21, 2017 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Timothy Morgan, MD
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Hepatitis
Keywords
survival, pegfilgrastim, cirrhosis, alcoholic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
prednisolone or pentoxifylline + pegfiltrastim
Arm Type
Experimental
Arm Description
prednisolone or pentoxifylline for 28 days PO plus pegfilgrastim subcutaneous weekly shot
Arm Title
prednisolone or pentoxifylline
Arm Type
Active Comparator
Arm Description
prednisolone or pentoxifylline for 28 days
Intervention Type
Drug
Intervention Name(s)
Standard of care + pegfiltrastim
Other Intervention Name(s)
Neulasta®
Intervention Description
prednisolone or pentoxifyline orally for 28 days + pegfilgrastim (Neulasta®) 6 mg in 0.6 mL SQ
Intervention Type
Drug
Intervention Name(s)
Standard of care
Other Intervention Name(s)
prednisolone or pentoxifyline
Intervention Description
Oral prednisolone or pentoxifyline for 28 days only
Primary Outcome Measure Information:
Title
Adverse events, especially infection and renal failure, Change in MELD Score and DF between Day 1 and Day 29, Lille score (at Day 8)
Description
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%.
Time Frame
Day 1, Day 8, Day 29, and Day 90
Secondary Outcome Measure Information:
Title
adverse events
Description
adverse events through Week 24
Time Frame
24 weeks
Title
Liver function
Description
Change in MELD and Maddrey DF during first 4 weeks
Time Frame
Day 29
Title
liver function
Description
Change in Lille score
Time Frame
Day 8
Title
Survival
Description
survival at Day 90
Time Frame
at Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Morgan, MD
Organizational Affiliation
VA Long Beach Healthcare System
Official's Role
Study Chair
Facility Information:
Facility Name
VA Loma Linda Healthcare System
City
Loma Linda
State/Province
California
ZIP/Postal Code
92357
Country
United States
Facility Name
VA Long Beach Healthcare System
City
Long Beach
State/Province
California
ZIP/Postal Code
98022
Country
United States
Facility Name
LAC-USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States
Facility Name
Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
New Mexico VA Health Care System
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patients' coded data will be shared .
Citations:
PubMed Identifier
36267499
Citation
Tayek JA, Stolz AA, Nguyen DV, Fleischman MW, Donovan JA, Alcorn JM, Chao DC, Asghar A, Morgan TR; Southern California Alcoholic Hepatitis (SCAH) Consortium. A phase II, multicenter, open-label, randomized trial of pegfilgrastim for patients with alcohol-associated hepatitis. EClinicalMedicine. 2022 Oct 12;54:101689. doi: 10.1016/j.eclinm.2022.101689. eCollection 2022 Dec.
Results Reference
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Pegfilgrastim in Patients With Alcoholic Hepatitis

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