Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy
NCT ID: NCT04816916
Last Updated: 2022-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
12 participants
INTERVENTIONAL
2021-06-29
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AXA1665 53.8 g per day
AXA1665 administered orally TID
AXA1665
AXA1665 administered TID with food
Matching placebo
Placebo administered orally TID
Placebo
Matching placebo administered TID with food
Interventions
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AXA1665
AXA1665 administered TID with food
Placebo
Matching placebo administered TID with food
Eligibility Criteria
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Inclusion Criteria
* Male and female adults aged ≥18 years.
* History of cirrhosis and at least 1 prior episode of overt hepatic encephalopathy (OHE) prior to Screening.
* A PHES of ≤ -4 during Screening.
* MELD score of ≤ 22 at Screening.
* Support of a primary caregiver who is able and willing to give written informed consent.
Exclusion Criteria
* Presence of Child's-Pugh score ≥12, hepato-renal syndrome(s), refractory ascites, or spontaneous bacterial peritonitis (SBP).
* History of a surgical portosystemic or a transjugular intrahepatic portosystemic shunt (TIPS) placement.
* Expectation of a liver transplant during the study.
* Use of marijuana or tetrahydrocannabinol (THC) within 1 week prior to Screening and during the study.
18 Years
ALL
No
Sponsors
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Axcella Health, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Andres Duarte-Rojo, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of California, San Francisco (UCSF)
San Francisco, California, United States
OMEGA Research Consultants
DeBary, Florida, United States
UF Hepatology Research at CTRB
Gainesville, Florida, United States
Homestead Associates in Research
Miami, Florida, United States
University of Miami
Miami, Florida, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Mercy Medical Center
Baltimore, Maryland, United States
New York University (NYU) School of Medicine
New York, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
Cumberland Research Associates
Fayetteville, North Carolina, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Optimed Research
Edinburg, Texas, United States
Baylor Scott & White Research Institute
Fort Worth, Texas, United States
Advanced Liver Therapies at St. Luke's Episcopal Hospital
Houston, Texas, United States
Pinnacle Clinical Research
San Antonio, Texas, United States
University of Virginia School of Medicine
Charlottesville, Virginia, United States
Bon Secours Liver Institute
Newport News, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
McGuire Research Institute, Inc., McGuire VA Medical Center
Richmond, Virginia, United States
University of Calgary
Calgary, Alberta, Canada
LMC Diabetes & Endocrinology Ltd. - London
London, Ontario, Canada
The Ottawa Hospital
Ottawa, , Canada
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, , Hungary
Azienda Ospedaliera Universitaria Federico II
Naples, , Italy
Azienda sanitaria universitaria Friuli Centrale (ASU FC)
Udine, , Italy
KO - MED Centra Kliniczne Lublin II
Lublin, , Poland
ID Clinic
Mysłowice, , Poland
SONOMED Sp. z o.o.
Szczecin, , Poland
Prywatna Specjalistyczna Praktyka Lekarska Jan Gietka
Warsaw, , Poland
Centrum Badan Klinicznych Piotr Napora Lekarze Sp. p.
Wroclaw, , Poland
Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
Barcelona, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Puerta de Hierro
Majadahonda, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
The Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
Countries
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Related Links
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EMMPOWER Phase 2 Clinical Trial Homepage
Other Identifiers
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AXA1665-101
Identifier Type: -
Identifier Source: org_study_id
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