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NCT03585257 · ClinicalTrials.gov registry record · Phase 2
HEAL STUDY (Hepatic Encephalopathy and Albumin Study)
A Phase 2 study, sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT03585257: Completed Phase 2 study, sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center.
NCT03585257 is a Phase 2 study that has completed, run by Hunter Holmes Mcguire Veteran Affairs Medical Center. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03585257, a Phase 2 study, has completed, sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
Patients with continued cognitive impairment after episodes of HE have few options beyond lactulose and rifaximin in the US. Therefore using IV albumin in a randomized, double-blind, placebo-controlled trial, which could beneficially impact inflammation, could be an additional approach to improve cognition. This 6 week trial will study changes in cognition, HRQOL and inflammation in patients with covert HE after prior overt HE using multiple IV albumin infusions vs. placebo.
Primary Outcome
Cognitive improvement on PHES
Interventions
- OTHER Placebo
- BIOLOGICAL 25% IV albumin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2018-06-20 |
| Est. Completion | 2022-03-30 |
| Phase | Phase 2 |
What the finished NCT03585257 record still lists
NCT03585257 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03585257 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03585257 about?
NCT03585257 is a clinical study titled "HEAL STUDY (Hepatic Encephalopathy and Albumin Study)". Patients with continued cognitive impairment after episodes of HE have few options beyond lactulose and rifaximin in the US. Therefore using IV albumin in a randomized, double-blind, placebo-controlled trial, which could beneficially impact inflammation, could be an additional approach to improve co...
What is the current status of trial NCT03585257?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2018-06-20. Estimated completion is 2022-03-30.
What interventions are being tested in trial NCT03585257?
The interventions under investigation include: Placebo (OTHER), 25% IV albumin (BIOLOGICAL).
Who is sponsoring clinical trial NCT03585257?
This trial is sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03585257's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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