Clinical Trial Details

Trial ID: L0356
Source ID: NCT02279524
Associated Drug: Aramchol
Title: A Clinical Trial to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With NASH
Acronym: Aramchol_005
Status: Completed
Study Results: Has Results
Results: https://ClinicalTrials.gov/show/NCT02279524/results
Conditions: Fatty Liver|Non-Alcoholic Steatohepatitis|Liver Diseases|Liver Fibroses
Interventions: Drug: Aramchol
Outcome Measures: Change From Baseline in Mean Liver Fat|NASH Resolution Without Worsening of Fibrosis|Fibrosis Improvement Without Worsening of NASH|Change From Baseline to Week 52/Termination in ALT
Sponsor/Collaborators: Galmed Research and Development, Ltd.|Sharp Clinical Services|Diamond Pharma Services Regulatory Affairs Consultancy|Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico|ClinIntel|Itamar-Medical, Israel|One Way Liver OWL|Medical University of Graz|T
Gender: All
Age: 18 Years to 75 Years ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 247
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
Start Date: April 29, 2015
Completion Date: May 22, 2018
Results First Posted: July 14, 2021
Last Update Posted: July 14, 2021
Locations: Profil Institue for Clinical Research Inc., Chula Vista, California, United States|Cedars-Sinai Medical Center, Los Angeles, California, United States|California Liver Research Institute, Pasadena, California, United States|Inland Empoire Liver Foundation, Rialto, California, United States|University of California Department of Medicine Division of Gastroenterology, San Diego, California, United States|Orange County Research Center, Tustin, California, United States|Indiana University, Indianapolis, Indiana, United States|Mount Sinai, New York, New York, United States|Columbia University Medical Center, New York, New York, United States|Duke University Medical Center, Durham, North Carolina, United States|Wake Research, Raleigh, North Carolina, United States|Texas Digestive Disease Consultants, Dallas, Texas, United States|Brooke Army Medical Center, Fort Sam Houston, Texas, United States|Gastroenterology Consultants of San Antonio, Live Oak, Texas, United States|Texas Liver Institute San Antonio, San Antonio, Texas, United States|Clinical Trials of Texas, San Antonio, Texas, United States|University of Virginia Medical Center, Charlottesville, Virginia, United States|Biomedica Research Group, Santiago, Chile|Centro de Investigacion Clinica CEIC, Santiago, Chile|Hospital Clinico Universidad de Chile, Santiago, Chile|Pontificia Universidad Catolica de Chile, Santiago, Chile|Centro de Investigaciones Clinicas Vina del Mar, Vina del Mar, Chile|Centre Hospitalier Universitaire (CHU) d'Angers, Angers, France|Centre Hospitalier Universitaire Dijon Bourgogne, Dijon, France|San Joseph Service Hepato Gastro Entrologie, Marseille, France|Hospital Saint Eloi, Montpellier, France|CHU Centre Hospiatalier Universitaire de Rennes, Paris, France|Hospital Pitie-Salpetriere, Paris, France|Hospital Saint-Antoine AP-HP, Paris, France|Hopital Paul Brousse, Villejuif, France|Unimed Adjara, Batumi, Georgia|Clinic Cortex, Tbilisi, Georgia|David Tatishvili Medical Center, Tbilisi, Georgia|LTD Diacor, Tbilisi, Georgia|Research Institute of Clinical Medicine, Tbilisi, Georgia|Medizinische Hochschule, Hannover, Germany|EUGASTRO GmbH, Leipzig, Germany|Universitat Leipzig Medizinische Fakultat, Leipzig, Germany|Humanity & Health Medical Centre, Central, Hong Kong|Carmel Medical Center, Haifa, Israel|Rambam Medical Center, Haifa, Israel|Hadassah Ein Karem Medical Cente, Jerusalem, Israel|Naharia Medical Center, Nahariya, Israel|The Holy family Medical Center, Nazareth, Israel|Sheba Medical Center, Ramat Gan, Israel|Tel-Aviv Saurasky Medical Center, Tel-Aviv, Israel|Asaf Harofeh Medical Center, Zrifin, Israel|Spedali Civili di Brescia, Brescia, Italy|A.O. San Paolo, Milano, Italy|Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy|A.O. U. "Federico II" di Napoli, Napoli, Italy|Azienda Ospedaliera di Rilievo Nazionale "A.Cardarelli", Napoli, Italy|Azienda Ospidaliera Universitaria Seconda Universita di Napoli, Napoli, Italy|A.O.U. Maggiore della Carit??, Novara, Italy|"Ospedale Cristo Re" dell'Istituto Figlie di N.S. al Monte Calvario, Roma, Italy|Fondazione Policlinico di Tor Vergata, Roma, Italy|Ospedale San Camillo, Roma, Italy|Policlinico A. Gemelli, Roma, Italy|Policlinico Umberto I Di Roma, Roma, Italy|Policlinico Univestitario Campus Biomedico, Roma, Italy|Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Kaunas, Lithuania|Klaipeda University Hospital, Klaipeda, Lithuania|Vilinius University Hospital Santariskiu Klinikos, Vilnius, Lithuania|Unidad de H??gado Hospital Universitario Dr. Jos?? Eleuterio Gonz??lez, Monterrey, Nuevo Le??n, Mexico|JM Research, Cuernavaca, Mexico|Consultorio M??dico, Metepec, Mexico|Torre de Consultorios Clinica Londres, Mexico City, Mexico|Consultorio Medico, Mexico City, Mexico|Instituto de Ciencias Medicas y de la Nutricion Salvador Zubiran, Mexico City, Mexico|Torre de Consultorios Clinica Londres, Mexico Distrito Federal, Mexico|Accelerium Clinical Research, Monterrey, Mexico|Consultorio Medico del Dr. Mauricio Castillo Barradas, M??xico Distrito Federal, Mexico|"Angeles Valle oriente" Hospital, San Pedro Garza Garcia, Mexico|Clinical Institute Colentina, Bucharest, Romania|The National Institute for Infectious Diseases "Prof. Dr. Matei Bals", Clinical Department for Adults II, Bucharest, Romania|Cluj County Emergency Hospital, Cluj Napoca, Romania|TVM Medical, Cluj Napoca, Romania|County Hospital Mures-Gastroenterology Department, Targu Mures, Romania
URL: https://ClinicalTrials.gov/show/NCT02279524