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NCT02776059
Pegfilgrastim in Patients With Alcoholic Hepatitis
Phase 2 trial testing Standard of care + pegfiltrastim in Alcoholic Hepatitis in 34 participants. Completed in 31 March 2021.
31 March 2020
Quick facts
| Lead sponsor | Timothy Morgan, MD |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 34 |
| Start date | 21 January 2017 |
| Primary completion | 31 March 2020 |
| Estimated completion | 31 March 2021 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- Standard of care + pegfiltrastim — full drug profile →
- Standard of care
Conditions studied
- Alcoholic Hepatitis — all drugs for Alcoholic Hepatitis →
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):
-
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 -
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 -
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 -
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 -
Current Management and Future Treatment of Alcoholic Hepatitis.
Mitchell MC, Kerr T, Herlong HF. · · 2020 · cited 12× · PMID 34035720 -
Alcoholic Hepatitis.
Gougol A, Clemente-Sanchez A, Argemi J, Bataller R. · · 2021 · cited 7× · PMID 34584675 · DOI 10.1002/cld.1092 -
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 -
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
Verify or expand the search:
- PubMed search for NCT02776059
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Alcoholic Hepatitis
Currently open trials in the same condition.
- NCT06919458 — Short Course Steroids in Alcohol Associated Hepatitis · Phase 3 · recruiting
- NCT06307964 — Intra-Hepatic Microbiota in Alcoholic Hepatitis · recruiting
- NCT05006430 — Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis · Phase 1, PHASE2 · recruiting
- NCT05018481 — HA35 Moderate Alcoholic Hepatitis (AH) Study · EARLY_PHASE1 · recruiting
- NCT02473341 — Gut-Liver Axis Modulation With IgG-Enriched Immunotherapy in Severe Alcohol-Associated Hepatitis · Phase 3 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02776059 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Timothy Morgan, MD
- Last refreshed: 29 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02776059.
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