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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 is a Phase 2 study that has completed, run by Hunter Holmes Mcguire Veteran Affairs Medical Center. The registered enrollment target is 48 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03585257
The ClinicalTrials.gov registry entry for NCT03585257 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hunter Holmes Mcguire Veteran Affairs Medical Center, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03585257 reports 0 study locations.
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.
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