Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement
Recruiting
Phase 2
Interventional Study
Cirrhosis
Hepatic Encephalopathy
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 30 (estimated)
- Sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical Center · Federal
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About This Trial
Hypothesis: Improvement in cognitive dysfunction with IV albumin in patients with cirrhosis with prior HE and MHE lasts for several weeks after albumin infusion has ended, and is due to persistent improvement in inflammatory markers, endothelial dysfunction, albumin function and gut microbial changes.
This will be a single-arm, single-blind sequential trial of IV 25% albumin and IV saline over 8 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age \>18 years
* Cirrhosis diagnosed using either (a) liver biopsy, (b) transient wave elastography (\>20 KPa) (c) radiological evidence consistent with cirrhosis, (d) in a patient with chronic liver disease endoscopic or radiological evidence of varices (e), in a patient with…
Contacts