Clinical Trial: Pegfilgrastim in Patients With Alcoholic Hepatitis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Timothy Morgan, MD

Current Primary Outcome: Adverse events, especially infection and renal failure, Change in MELD Score and DF between Day 1 and Day 29, Lille score (at Day 8) [ Time Frame: 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%.


Original Primary Outcome: Proportion of participants with overall survival at 90 days [ Time Frame: 90 days ]

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%.


Current Secondary Outcome:

  • adverse events [ Time Frame: 24 weeks ]
    adverse events through Week 24
  • Liver function [ Time Frame: Day 29 ]
    Change in MELD and Maddrey DF during first 4 weeks
  • liver function [ Time Frame: Day 8 ]
    Change in Lille score
  • Survival [ Time Frame: at Day 90 ]
    survival at Day 90


Original Secondary Outcome:

  • adverse events [ Time Frame: 24 weeks ]
    adverse events through Week 24
  • Liver function [ Time Frame: Day 29 ]
    Change in MELD and Maddrey DF during first 4 weeks
  • liver function [ Time Frame: 1 week ]
    Change in Lille score
  • Survival [ Time Frame: 4 weeks and 24 weeks ]
    survival at week 4 and week 24


Information By: Southern California Institute for Research and Education

Dates:
Date Received: May 10, 2016
Date Started: June 2016
Date Completion: December 2033
Last Updated: May 18, 2016
Last Verified: May 2016