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| ID | Type | Description | Link |
|---|---|---|---|
| 5U01AA021886 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prednisolone or pentoxifylline + pegfiltrastim | Experimental | prednisolone or pentoxifylline for 28 days PO plus pegfilgrastim subcutaneous weekly shot |
|
| prednisolone or pentoxifylline | Active Comparator | prednisolone or pentoxifylline for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of care + pegfiltrastim | Drug | prednisolone or pentoxifyline orally for 28 days + pegfilgrastim (Neulasta®) 6 mg in 0.6 mL SQ |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | adverse events through Week 24 | 24 weeks |
| Liver function | Change in MELD and Maddrey DF during first 4 weeks | Day 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Morgan, MD | VA Long Beach Healthcare System | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Loma Linda Healthcare System | Loma Linda | California | 92357 | United States | ||
| VA Long Beach Healthcare System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36267499 | Derived | Tayek JA, Stolz AA, Nguyen DV, Fleischman MW, Donovan JA, Alcorn JM, Chao DC, Asghar A, Morgan TR; Southern California Alcoholic Hepatitis (SCAH) Consortium. A phase II, multicenter, open-label, randomized trial of pegfilgrastim for patients with alcohol-associated hepatitis. EClinicalMedicine. 2022 Oct 12;54:101689. doi: 10.1016/j.eclinm.2022.101689. eCollection 2022 Dec. |
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Patients' coded data will be shared .
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| ID | Term |
|---|---|
| D006519 | Hepatitis, Alcoholic |
| D008104 | Liver Cirrhosis, Alcoholic |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008108 | Liver Diseases, Alcoholic |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| C455861 | pegfilgrastim |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard of care | Drug | Oral prednisolone or pentoxifyline for 28 days only |
|
|
| liver function | Change in Lille score | Day 8 |
| Survival | survival at Day 90 | at Day 90 |
| Long Beach |
| California |
| 98022 |
| United States |
| LAC-USC Medical Center | Los Angeles | California | 90089 | United States |
| Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| New Mexico VA Health Care System | Albuquerque | New Mexico | 87108 | United States |
| D020751 |
| Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |