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Pegfilgrastim in Patients With Alcoholic Hepatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02776059
Recruitment Status : Recruiting
First Posted : May 18, 2016
Last Update Posted : March 17, 2020
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Timothy Morgan, MD, Southern California Institute for Research and Education

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.

Condition or disease Intervention/treatment Phase
Alcoholic Hepatitis Drug: Standard of care + pegfiltrastim Drug: Standard of care Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of Pegfilgrastim (Neulasta®) in Patients With Alcoholic Hepatitis
Actual Study Start Date : February 21, 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2033


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 Name: 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 Name: prednisolone or pentoxifyline




Primary Outcome Measures :
  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) [ 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%.


Secondary Outcome Measures :
  1. adverse events [ Time Frame: 24 weeks ]
    adverse events through Week 24

  2. Liver function [ Time Frame: Day 29 ]
    Change in MELD and Maddrey DF during first 4 weeks

  3. liver function [ Time Frame: Day 8 ]
    Change in Lille score

  4. Survival [ Time Frame: at Day 90 ]
    survival at Day 90



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02776059


Contacts
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Contact: Timothy Morgan, MD 562 826 5756 timothy.morgan@va.gov
Contact: Aliya Asghar, MPH 562 826 5212 aliya.asghar@va.gov

Locations
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United States, California
VA Loma Linda Healthcare System Recruiting
Loma Linda, California, United States, 92357
Contact: Daniel C Chao, MD    909-825-7084 ext 6141    Daniel.Chao@va.gov   
Principal Investigator: Daniel C Chao, MD         
VA Long Beach Healthcare System Recruiting
Long Beach, California, United States, 98022
Contact: Timothy Morgan, MD    562-826-5756    timothy.morgan@va.gov   
Contact: Aliya Asghar, MPH    562 826 5212    Aliya.asghar@va.gov   
LAC-USC Medical Center Recruiting
Los Angeles, California, United States, 90089
Contact: Andrew Stolz, MD    323-442-2699    astolz@usc.edu   
Harbor-UCLA Medical Center Recruiting
Torrance, California, United States, 90502
Contact: John Tayek, MD    310-222-1237    jtayek@ladhs.org   
Contact: Michael W Fleischman, MD    310 222-2475    wfleischman@labiomed.org   
United States, New Mexico
New Mexico VA Health Care System Recruiting
Albuquerque, New Mexico, United States, 87108
Contact: Joseph M. Alcorn, MD    505-265-1711 ext 4801    Joseph.Alcorn@va.gov   
Principal Investigator: Joseph M. Alcorn, MD         
Sponsors and Collaborators
Timothy Morgan, MD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Study Chair: Timothy Morgan, MD VA Long Beach Healthcare System
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Responsible Party: Timothy Morgan, MD, Chief of Hepatology, Southern California Institute for Research and Education
ClinicalTrials.gov Identifier: NCT02776059    
Other Study ID Numbers: SCAH Consortium- AH Treatment
5U01AA021886 ( U.S. NIH Grant/Contract )
First Posted: May 18, 2016    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patients' coded data will be shared .

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Timothy Morgan, MD, Southern California Institute for Research and Education:
survival
pegfilgrastim
cirrhosis, alcoholic
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Hepatitis, Alcoholic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Prednisolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents