Trials / Terminated
TerminatedNCT04816916
Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of AXA1665 in Subjects With Liver Cirrhosis and Prior Overt Hepatic Encephalopathy (EMMPOWER)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Axcella Health, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a global study to compare the effects of AXA1665, an orally active mixture of amino acids, compared to placebo, on cognitive and physical function, as well as the safety and tolerability of AXA1665.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AXA1665 | AXA1665 administered TID with food |
| DRUG | Placebo | Matching placebo administered TID with food |
Timeline
- Start date
- 2021-06-29
- Primary completion
- 2022-06-30
- Completion
- 2022-06-30
- First posted
- 2021-03-25
- Last updated
- 2022-07-27
Locations
40 sites across 7 countries: United States, Canada, Hungary, Italy, Poland, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04816916. Inclusion in this directory is not an endorsement.