NCT02776059

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2017

Typical duration for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 18, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

January 21, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

3.2 years

First QC Date

May 10, 2016

Last Update Submit

September 23, 2021

Conditions

Alcoholic Hepatitis

Keywords

survivalpegfilgrastimcirrhosis, alcoholic

Outcome Measures

Primary Outcomes (1)

  • 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%.

    Day 1, Day 8, Day 29, and Day 90

Secondary Outcomes (4)

  • adverse events

    24 weeks

  • Liver function

    Day 29

  • liver function

    Day 8

  • Survival

    at Day 90

Study Arms (2)

prednisolone or pentoxifylline + pegfiltrastim

EXPERIMENTAL

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

Drug: Standard of care + pegfiltrastim

prednisolone or pentoxifylline

ACTIVE COMPARATOR

prednisolone or pentoxifylline for 28 days

Drug: Standard of care

Interventions

Standard of care + pegfiltrastimDRUG

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

Also known as: Neulasta®
prednisolone or pentoxifylline + pegfiltrastim
Standard of careDRUG

Oral prednisolone or pentoxifyline for 28 days only

Also known as: prednisolone or pentoxifyline
prednisolone or pentoxifylline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A clinical diagnosis of alcoholic hepatitis with Maddrey's discriminant function score ≥32. Age 18 years or older.

You may not qualify if:

  • Renal failure (creatinine \>2.0 mg/dl)
  • Bilirubin \<5 mg/dL
  • uncontrolled recent upper gastrointestinal bleeding
  • Known HIV infection
  • Uncontrolled infection, or pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

VA Loma Linda Healthcare System

Loma Linda, California, 92357, United States

Location

VA Long Beach Healthcare System

Long Beach, California, 98022, United States

Location

LAC-USC Medical Center

Los Angeles, California, 90089, United States

Location

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

New Mexico VA Health Care System

Albuquerque, New Mexico, 87108, United States

Location

Related Publications (1)

  • 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.

    PMID: 36267499DERIVED

MeSH Terms

Conditions

Hepatitis, AlcoholicLiver Cirrhosis, Alcoholic

Interventions

Standard of CarepegfilgrastimPrednisolone

Condition Hierarchy (Ancestors)

HepatitisLiver DiseasesDigestive System DiseasesLiver Diseases, AlcoholicAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersLiver CirrhosisFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Timothy Morgan, MD

    VA Long Beach Healthcare System

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief of Hepatology

Study Record Dates

First Submitted

May 10, 2016

First Posted

May 18, 2016

Study Start

January 21, 2017

Primary Completion

March 31, 2020

Study Completion

March 31, 2021

Last Updated

September 29, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

Patients' coded data will be shared .

Locations

US(5)