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NCT02776059

Pegfilgrastim in Patients With Alcoholic Hepatitis

Completed Phase 2 Last updated 29 September 2021
What this trial tests

Phase 2 trial testing Standard of care + pegfiltrastim in Alcoholic Hepatitis in 34 participants. Completed in 31 March 2021.

Timeline
21 January 2017
Primary endpoint
31 March 2020
31 March 2021

Quick facts

Lead sponsorTimothy Morgan, MD
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment34
Start date21 January 2017
Primary completion31 March 2020
Estimated completion31 March 2021
Sites5 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Timothy Morgan, MD — full company profile →

Who can join

18 and older, any sex, with Alcoholic Hepatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The knowns and unknowns of treatment for alcoholic hepatitis.
    Sehrawat TS, Liu M, Shah VH. · · 2020 · cited 76× · PMID 32277902 · DOI 10.1016/s2468-1253(19)30326-7
  2. Epidemiological Realities of Alcoholic Liver Disease: Global Burden, Research Trends, and Therapeutic Promise.
    Xiao J, Wang F, Wong NK, Lv Y, et al · · 2020 · cited 28× · PMID 32690129 · DOI 10.3727/105221620x15952664091823
  3. Interleukin-22 in alcoholic hepatitis and beyond.
    Xiang X, Hwang S, Feng D, Shah VH, et al · · 2020 · cited 25× · PMID 32892258 · DOI 10.1007/s12072-020-10082-6
  4. A phase II, multicenter, open-label, randomized trial of pegfilgrastim for patients with alcohol-associated hepatitis.
    Tayek JA, Stolz AA, Nguyen DV, Fleischman MW, et al · · 2022 · cited 23× · PMID 36267499 · DOI 10.1016/j.eclinm.2022.101689
  5. Current Management and Future Treatment of Alcoholic Hepatitis.
    Mitchell MC, Kerr T, Herlong HF. · · 2020 · cited 12× · PMID 34035720
  6. Alcoholic Hepatitis.
    Gougol A, Clemente-Sanchez A, Argemi J, Bataller R. · · 2021 · cited 7× · PMID 34584675 · DOI 10.1002/cld.1092
  7. Granulocyte colony-stimulating factor with or without stem or progenitor cell or growth factors infusion for people with compensated or decompensated advanced chronic liver disease.
    Colli A, Fraquelli M, Prati D, Casazza G. · · 2023 · cited 6× · PMID 37278488 · DOI 10.1002/14651858.cd013532.pub2
  8. The future of therapy for alcoholic hepatitis - Beyond corticosteroids.
    Vergis N, Atkinson SR, Thursz MR. · · 2019 · cited 5× · PMID 30791978 · DOI 10.1016/j.jhep.2019.01.016

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Other recruiting trials for Alcoholic Hepatitis

Currently open trials in the same condition.

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