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NCT04550481 · ClinicalTrials.gov registry record · Phase 2
Role of Lisinopril in Preventing the Progression of Non-Alcoholic Fatty Liver Disease, RELIEF-NAFLD Study
A Phase 2 study of Hepatocellular Carcinoma and Nonalcoholic Steatohepatitis, sponsored by Northwestern University.
- Active
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
- 4
- Study locations
NCT04550481: Active Phase 2 study of Hepatocellular Carcinoma and Nonalcoholic Steatohepatitis, sponsored by Northwestern University.
NCT04550481 is a Phase 2 study of Hepatocellular Carcinoma and Nonalcoholic Steatohepatitis that is active but no longer recruiting, run by Northwestern University. The registered enrollment target is 45 participants, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (82% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04550481, a Phase 2 study of Hepatocellular Carcinoma and Nonalcoholic Steatohepatitis, is active but no longer recruiting, sponsored by Northwestern University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
- 4
- Study locations
Study Summary
This phase II trial investigates how well lisinopril may work in preventing the progression of non-alcoholic fatty liver disease (NAFLD). NAFLD is a condition where there is an accumulation of fatty cells in the liver. NAFLD increases a person's risk of developing liver cancer. Liver fibrosis is the common finding of chronic liver diseases leading to reduced liver function. Lisinopril is a medication that is commonly used to treat high blood pressure. Lisinopril may help to decrease liver fibrosis. The purpose of this trial is to find out what effect, if any, lisinopril has on a patient's risk of developing liver cancer.
Primary Outcome
Descriptive statistics will be used to summarize changes and values at each time point. The primary analysis will be performed using a paired t-test to compare the pre- to post-treatment changes in PRO-C3 levels. PRO-C3 levels will be log-transformed to satisfy the normality assumption. If log-transformation does not satisfy the normality assumption, a signed rank test will be used.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Liver Ultrasonographic Elastography
- PROCEDURE Magnetic Resonance Elastography
- DRUG Lisinopril
Study Locations (4)
California
- Cedars Sinai Medical Center - Los Angeles
Minnesota
- Mayo Clinic in Rochester - Rochester
New York
- Mount Sinai Hospital - New York
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2021-05-11 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 2 |
What the registry record for NCT04550481 still lists
NCT04550481 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (82% lower).
The record links to 2 conditions, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04550481 reports a single indexed study location in California, Minnesota, New York.
Frequently Asked Questions
What is clinical trial NCT04550481 about?
NCT04550481 is a clinical study titled "Role of Lisinopril in Preventing the Progression of Non-Alcoholic Fatty Liver Disease, RELIEF-NAFLD Study". This phase II trial investigates how well lisinopril may work in preventing the progression of non-alcoholic fatty liver disease (NAFLD). NAFLD is a condition where there is an accumulation of fatty cells in the liver. NAFLD increases a person's risk of developing liver cancer. Liver fibrosis is the...
What is the current status of trial NCT04550481?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2021-05-11. Estimated completion is 2026-09-30.
What conditions does trial NCT04550481 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma, Nonalcoholic Steatohepatitis.
What interventions are being tested in trial NCT04550481?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Liver Ultrasonographic Elastography (PROCEDURE), Magnetic Resonance Elastography (PROCEDURE), Lisinopril (DRUG).
Who is sponsoring clinical trial NCT04550481?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04550481 being conducted?
This trial has 4 study locations across California, Minnesota, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04550481's enrollment target sits among peer trials
45 88th of 145 higher than 56 of 145 other Hepatocellular Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatocellular Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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