Alcoholic Hepatitis
Conditions
Keywords
survival, pegfilgrastim, cirrhosis, alcoholic
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.
Interventions
DRUGStandard of care + pegfiltrastim
prednisolone or pentoxifyline orally for 28 days + pegfilgrastim (Neulasta®) 6 mg in 0.6 mL SQ
DRUGStandard of care
Oral prednisolone or pentoxifyline for 28 days only
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Timothy Morgan, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events, especially infection and renal failure, Change in MELD Score and DF between Day 1 and Day 29, Lille score (at Day 8) | 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
| Measure | Time frame | Description |
|---|---|---|
| adverse events | 24 weeks | adverse events through Week 24 |
| Liver function | Day 29 | Change in MELD and Maddrey DF during first 4 weeks |
| liver function | Day 8 | Change in Lille score |
| Survival | at Day 90 | survival at Day 90 |
Countries
United States
Outcome results
None listed