Pegfilgrastim in Patients With Alcoholic Hepatitis
| Status: | Recruiting |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/30/2018 |
| Start Date: | February 21, 2017 |
| End Date: | December 2033 |
| Contact: | Timothy Morgan, MD |
| Email: | timothy.morgan@va.gov |
| Phone: | 562 826 5756 |
A Phase II, Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of Pegfilgrastim (Neulasta®) 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.
care + pegfilgrastim (Neulasta®) among patients with a clinical diagnosis of alcoholic
hepatitis and DF≥32.
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.
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.
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.
We found this trial at
5
sites
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Albuquerque, New Mexico 87108
Principal Investigator: Joseph M. Alcorn, MD
Phone: 505-265-1711
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Loma Linda, California 92357
Principal Investigator: Daniel C Chao, MD
Phone: 909-825-7084
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