Clinical trial NCT02776059: Pegfilgrastim in Patients With Alcoholic Hepatitis
Official title: A Phase II, Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of Pegfilgrastim (Neulasta®) in Patients With Alcoholic Hepatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcoholic Hepatitis
Keywords: survival
pegfilgrastim
cirrhosis, alcoholic
Lead sponsor: Southern California Institute for Research and Education
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2016-05-18
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Adverse events, especially infection and renal failure, Change in MELD Score and DF between Day 1 and Day 29, Lille score (at Day 8)
timeFrame: Day 1, Day 8, Day 29, and Day 90
Secondary outcomes:
measure: adverse events
timeFrame: 24 weeks
measure: Liver function
timeFrame: Day 29
measure: liver function
timeFrame: Day 8
measure: Survival
timeFrame: at Day 90
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: VA Loma Linda Healthcare System
state: California
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
city: Los Angeles
country: United States
facility: LAC-USC Medical Center
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
city: Albuquerque
country: United States
facility: New Mexico VA Health Care System
state: New Mexico
Study officials:
affiliation: VA Long Beach Healthcare System
name: Timothy Morgan, MD
role: STUDY_CHAIR
References:
citation: 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.