Pegfilgrastim in Patients With Alcoholic Hepatitis

Alcoholic Hepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02776059
• Other study ID #: SCAH Consortium- AH Treatment
• Secondary ID: 5U01AA021886
• Status: Completed
• Phase: Phase 2
• Start date: January 21, 2017
• Est. completion date: March 31, 2021

Study information

• Verified date: September 2021
• Source: Southern California Institute for Research and Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcoholic Hepatitis
• Hepatitis
• Hepatitis A
• Hepatitis, Alcoholic

Intervention

Drug:
• Standard of care + pegfiltrastim
prednisolone or pentoxifyline orally for 28 days + pegfilgrastim (Neulasta®) 6 mg in 0.6 mL SQ
• Standard of care
Oral prednisolone or pentoxifyline for 28 days only

Locations

Country	Name	City	State
United States	New Mexico VA Health Care System	Albuquerque	New Mexico
United States	VA Loma Linda Healthcare System	Loma Linda	California
United States	VA Long Beach Healthcare System	Long Beach	California
United States	LAC-USC Medical Center	Los Angeles	California
United States	Harbor-UCLA Medical Center	Torrance	California

Sponsors (2)

Lead Sponsor	Collaborator
Timothy Morgan, MD	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events, especially infection and renal failure, Change in MELD Score and DF between Day 1 and Day 29, Lille score (at Day 8)	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%.	Day 1, Day 8, Day 29, and Day 90
Secondary	adverse events	adverse events through Week 24	24 weeks
Secondary	Liver function	Change in MELD and Maddrey DF during first 4 weeks	Day 29
Secondary	liver function	Change in Lille score	Day 8
Secondary	Survival	survival at Day 90	at Day 90