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- | L-leucine/L-isoleucine/L-valine/L-lysine HCL/L-histidine/L-threonine/L-ornithine L-aspartate (AXA1665) / Axcella
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: EMMPOWER: Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy (clinicaltrials.gov) - Jul 27, 2022
P2, N=12, Terminated, Sponsor: Axcella Health, Inc
N=150 --> 12 | Trial completion date: Mar 2023 --> Jun 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Mar 2023 --> Jun 2022; Sponsor is stopping the study to focus company resources on other development programs.
- || L-leucine/L-isoleucine/L-valine/L-lysine HCL/L-histidine/L-threonine/L-ornithine L-aspartate (AXA1665) / Axcella
Enrollment closed: EMMPOWER: Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy (clinicaltrials.gov) - Jun 30, 2022
P2, N=150, Active, not recruiting, Sponsor: Axcella Health, Inc
N=150 --> 12 | Trial completion date: Mar 2023 --> Jun 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Mar 2023 --> Jun 2022; Sponsor is stopping the study to focus company resources on other development programs. Recruiting --> Active, not recruiting
- L-leucine/L-isoleucine/L-valine/L-lysine HCL/L-histidine/L-threonine/L-ornithine L-aspartate (AXA1665) / Axcella
[VIRTUAL] AXA1665 SHOWS DOSE-DEPENDENT ALTERATIONS IN METABOLIC PROFILE, INCLUDING REDUCTION OF NON-DOSED AROMATIC AMINO ACIDS, THAT DIFFERENTIATE IT FROM PROTEIN SUPPLEMENT IN HEALTHY SUBJECTS () - Oct 21, 2021 - Abstract #AASLD2021AASLD_478;
In contrast, PS administration results in increased systemic exposure of ArAAs . Thus, AXA1665 has the potential to address underlying AA imbalances associated with OHE in a targeted manner .
- ||| L-leucine/L-isoleucine/L-valine/L-lysine HCL/L-histidine/L-threonine/L-ornithine L-aspartate (AXA1665) / Axcella
Enrollment open: EMMPOWER: Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy (clinicaltrials.gov) - May 10, 2021
P2, N=150, Recruiting, Sponsor: Axcella Health, Inc
Thus, AXA1665 has the potential to address underlying AA imbalances associated with OHE in a targeted manner . Not yet recruiting --> Recruiting
- |||| L-leucine/L-isoleucine/L-valine/L-lysine HCL/L-histidine/L-threonine/L-ornithine L-aspartate (AXA1665) / Axcella
New P2 trial: EMMPOWER: Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy (clinicaltrials.gov) - Mar 24, 2021
P2, N=150, Not yet recruiting, Sponsor: Axcella Health, Inc
- ||| L-leucine/L-isoleucine/L-valine/L-lysine HCL/L-histidine/L-threonine/L-ornithine L-aspartate (AXA1665) / Axcella
Trial completion: Study of the Safety and Tolerability of AXA1665 in Subjects With Mild and Moderate Hepatic Insufficiency (clinicaltrials.gov) - Sep 17, 2020
P=N/A, N=60, Completed, Sponsor: Axcella Health, Inc
Not yet recruiting --> Recruiting Recruiting --> Completed
- ||| L-leucine/L-isoleucine/L-valine/L-lysine HCL/L-histidine/L-threonine/L-ornithine L-aspartate (AXA1665) / Axcella
New trial: Study of the Safety and Tolerability of AXA1665 in Subjects With Mild and Moderate Hepatic Insufficiency (clinicaltrials.gov) - Nov 3, 2019
P=N/A, N=60, Recruiting, Sponsor: Axcella Health, Inc