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New treatment option for Cirrhosis
Official title Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement
ClinicalTrials.gov ID: NCT06052176
What this study is testing
What is Albumin Infusion?
Albumin Infusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cirrhosis.
Also referred to as Albutein.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 weeks with biological sampling and cognitive and health related quality of life (HRQOL) testing with each subject acting as their own control.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 8 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \>18 years
- Cirrhosis diagnosed using either (a) liver biopsy, (b) transient wave elastography (\>20 KPa) (c) radiological evidence consistent with cirrhosis...
- Cognitive impairment defined by MHE on psychometric hepatic encephalopathy score (PHES), critical flicker frequency (CFF), or EncephalApp Stroop
- Prior HE controlled by lactulose or rifaximin for at least one month
- Serum albumin \<4gm/dl
You likely can't join if
- Unclear diagnosis of cirrhosis
- No prior overt HE
- No cognitive impairment on the tests noted
- Requiring regular albumin infusions within 3 months or anticipated during the study visit
- Infection within a month
- Allergies to albumin
See the full eligibility 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...
- Cognitive impairment defined by MHE on psychometric hepatic encephalopathy score (PHES), critical flicker frequency (CFF), or EncephalApp Stroop
- Prior HE controlled by lactulose or rifaximin for at least one month
- Serum albumin \<4gm/dl
- Unclear diagnosis of cirrhosis
- No prior overt HE
- No cognitive impairment on the tests noted
- Requiring regular albumin infusions within 3 months or anticipated during the study visit
- Infection within a month
- Allergies to albumin
- Unlikely to be adherent to the study
- Unable or unwilling to consent
- West Haven Criteria\>2
- Alcohol abuse within 1 month
- Serum albumin \>4gm/dl
- Congestive heart failure
The study team makes the final eligibility decision.
Where it's taking place
- Richmond, Virginia, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Richmond, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.