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NCT Number: NCT02776059

Pegfilgrastim 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.

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Key information

Conditions

Alcoholic Hepatitis Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Digestive System Diseases Fibrosis Hepatitis Hepatitis, Alcoholic Liver Cirrhosis Liver Cirrhosis, Alcoholic Liver Diseases Liver Diseases, Alcoholic Pathologic Processes Pathological Conditions, Signs and Symptoms Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

VA Loma Linda Healthcare System, Loma Linda, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard of care + pegfiltrastim

Drug

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

Other names: Neulasta®

Standard of care

Drug

Oral prednisolone or pentoxifyline for 28 days only

Other names: prednisolone or pentoxifyline

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)

    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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Timothy Morgan, MD

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
May 18, 2016
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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