NCT02776059

Pegfilgrastim in Patients With Alcoholic Hepatitis

A Phase II, Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of Pegfilgrastim (Neulasta®) in Patients With Alcoholic Hepatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Timothy Morgan, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcoholic Hepatitis

Interventions

Type	Name	Description
DRUG	Standard of care + pegfiltrastim	prednisolone or pentoxifyline orally for 28 days + pegfilgrastim (Neulasta®) 6 mg in 0.6 mL SQ
DRUG	Standard of care	Oral prednisolone or pentoxifyline for 28 days only

Timeline

• Start date: 2017-01-21
• Primary completion: 2020-03-31
• Completion: 2021-03-31
• First posted: 2016-05-18
• Last updated: 2021-09-29

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study