Alcoholic HepatitisPhase 2NCT02776059
Pegfilgrastim in Patients With Alcoholic Hepatitis
A Phase 2 study of Alcoholic Hepatitis, run by Timothy Morgan, MD at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholic Hepatitis
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 5 sitesUnited States
- Study dates
- 21 Jan 2017to 31 Mar 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A clinical diagnosis of alcoholic hepatitis with Maddrey's discriminant function score ≥32. Age 18 years or older.
Who cannot join
- Renal failure (creatinine >2.0 mg/dl)
- Bilirubin <5 mg/dL
- uncontrolled recent upper gastrointestinal bleeding
- Known HIV infection
- Uncontrolled infection, or pregnant.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
New Mexico VA Health Care System
Albuquerque, New Mexico, 87108
VA Loma Linda Healthcare System
Loma Linda, California, 92357
VA Long Beach Healthcare System
Long Beach, California, 98022
LAC-USC Medical Center
Los Angeles, California, 90089
Harbor-UCLA Medical Center
Torrance, California, 90502
About this study
Official title: 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.
Read the 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
- Being tested
- Standard of care + pegfiltrastim, Standard of care
- Keywords
- survival, pegfilgrastim, cirrhosis, alcoholic
- Medical subject headings
- Hepatitis, Alcoholic, Liver Cirrhosis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care + pegfiltrastimDrug
Also called Neulasta®
prednisolone or pentoxifyline orally for 28 days + pegfilgrastim (Neulasta®) 6 mg in 0.6 mL SQ
Standard of careDrug
Also called prednisolone or pentoxifyline
Oral prednisolone or pentoxifyline for 28 days only
| Study group | Role | What they receive |
|---|---|---|
| prednisolone or pentoxifylline + pegfiltrastim | Experimental | prednisolone or pentoxifylline for 28 days PO plus pegfilgrastim subcutaneous weekly shot Receives: Drug: Standard of care + pegfiltrastim |
| prednisolone or pentoxifylline | Active comparator | prednisolone or pentoxifylline for 28 days Receives: Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Day 1, Day 8, Day 29, and Day 90
Secondary outcomes (4)
adverse events
adverse events through Week 24
Measured: 24 weeks
Liver function
Change in MELD and Maddrey DF during first 4 weeks
Measured: Day 29
liver function
Change in Lille score
Measured: Day 8
Survival
survival at Day 90
Measured: at Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study start21 Jan 2017
- Primary completion31 Mar 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcoholic HepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Timothy Morgan, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor-investigator, Timothy Morgan, MD, Southern California Institute for Research and Education
- Investigators
- Timothy Morgan, MD, Study chair, VA Long Beach Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776059
- Sponsor's protocol ID
- SCAH Consortium- AH Treatment
- Other IDs
- 5U01AA021886
- Status last verified
- Sep 2021
- First submitted
- 10 May 2016
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patients' coded data will be shared .
Publications
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.
PubMed 36267499
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of Pegfilgrastim (Neulasta®) in Patients With Alcoholic Hepatitis
- ClinicalTrials.gov ID
- NCT02776059
- Acronym / sponsor ID
- SCAH Consortium- AH Treatment
- Conditions
- Alcoholic Hepatitis
- Keywords
- survival, pegfilgrastim, cirrhosis, alcoholic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Timothy Morgan, MDUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 21 Jan 2017 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 18 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prednisolone or pentoxifylline + pegfiltrastim | Experimental | Drug: Standard of care + pegfiltrastimprednisolone or pentoxifylline for 28 days PO plus pegfilgrastim subcutaneous weekly shot |
| prednisolone or pentoxifylline | Active comparator | Drug: Standard of careprednisolone or pentoxifylline for 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A clinical diagnosis of alcoholic hepatitis with Maddrey's discriminant function score ≥32. Age 18 years or older.
Key exclusion criteria (5 listed)
- Renal failure (creatinine >2.0 mg/dl)
- Bilirubin <5 mg/dL
- uncontrolled recent upper gastrointestinal bleeding
- Known HIV infection
- Uncontrolled infection, or pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of care + pegfiltrastimAlso: Neulasta®prednisolone or pentoxifyline orally for 28 days + pegfilgrastim (Neulasta®) 6 mg in 0.6 mL SQ | Drug | prednisolone or pentoxifylline + pegfiltrastim |
| Standard of careAlso: prednisolone or pentoxifylineOral prednisolone or pentoxifyline for 28 days only | Drug | prednisolone or pentoxifylline |
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%.
4 secondary outcomes
adverse events
Time frame: 24 weeks
Liver function
Time frame: Day 29
liver function
Time frame: Day 8
Survival
Time frame: at Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Derived from this study: PubMed 36267499Tayek 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.
- Individual participant dataSharing planned: Yes. Patients' coded data will be shared .
Related trials for Alcoholic Hepatitis
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Dysfunction-Associated Steatohepatitis
RecruitingPhase 2
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
RecruitingPhase 3
Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH)
Hepatitis
RecruitingObservational study
Blood Collection Biorepository for Liver Disease Research
Non-Alcoholic Steatohepatitis(NASH), Hepatitis C
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Morgan, MD study chair
VA Long Beach Healthcare System
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Alcoholic Hepatitis, run by Timothy Morgan, MD at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02776059, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.