A Clinical Trial to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With NASH

PHASE2CompletedINTERVENTIONAL
Enrollment

247

Participants

Timeline

Start Date

April 29, 2015

Primary Completion Date

May 22, 2018

Study Completion Date

May 22, 2018

Conditions
Fatty LiverNon-Alcoholic SteatohepatitisLiver DiseasesLiver Fibroses
Interventions
DRUG

Aramchol

"Subjects will be administered Aramchol as follows:~* One tablet of Aramchol 400 mg and one tablet of matching placebo for Aramchol.~* One tablet of Aramchol 400 mg and one tablet of Aramchol 200 mg.~* Two tablet of Aramchol matching placebo. The tablets should be taken orally in the morning within 30 min after breakfast with a glass of water (250 ml).~Subjects are allowed to omit study drugs up to 3 consecutive days during the study."

Trial Locations (78)

10029

Mount Sinai, New York

10032

Columbia University Medical Center, New York

22908

University of Virginia Medical Center, Charlottesville

27612

Wake Research, Raleigh

27710

Duke University Medical Center, Durham

46202

Indiana University, Indianapolis

75246

Texas Digestive Disease Consultants, Dallas

78215

Texas Liver Institute San Antonio, San Antonio

78229

Clinical Trials of Texas, San Antonio

78233

Gastroenterology Consultants of San Antonio, Live Oak

78234

Brooke Army Medical Center, Fort Sam Houston

90048

Cedars-Sinai Medical Center, Los Angeles

91105

California Liver Research Institute, Pasadena

91911

Profil Institue for Clinical Research Inc., Chula Vista

92103

University of California Department of Medicine Division of Gastroenterology, San Diego

92377

Inland Empoire Liver Foundation, Rialto

92780

Orange County Research Center, Tustin

400013

Cluj County Emergency Hospital, Cluj-Napoca

TVM Medical, Cluj-Napoca

Unknown

Biomedica Research Group, Santiago

Centro de Investigacion Clinica CEIC, Santiago

Hospital Clinico Universidad de Chile, Santiago

Pontificia Universidad Catolica de Chile, Santiago

Centro de Investigaciones Clinicas Vina del Mar, Viña del Mar

Centre Hospitalier Universitaire (CHU) d'Angers, Angers

Centre Hospitalier Universitaire Dijon Bourgogne, Dijon

San Joseph Service Hepato Gastro Entrologie, Marseille

Hospital Saint Eloi, Montpellier

CHU Centre Hospiatalier Universitaire de Rennes, Paris

Hospital Pitie-Salpetriere, Paris

Hospital Saint-Antoine AP-HP, Paris

Hopital Paul Brousse, Villejuif

Unimed Adjara, Batumi

Clinic Cortex, Tbilisi

David Tatishvili Medical Center, Tbilisi

LTD Diacor, Tbilisi

Research Institute of Clinical Medicine, Tbilisi

Medizinische Hochschule, Hanover

EUGASTRO GmbH, Leipzig

Universitat Leipzig Medizinische Fakultat, Leipzig

Humanity & Health Medical Centre, Central

Carmel Medical Center, Haifa

Rambam Medical Center, Haifa

Hadassah Ein Karem Medical Cente, Jerusalem

Naharia Medical Center, Nahariya

The Holy family Medical Center, Nazareth

Sheba Medical Center, Ramat Gan

Tel-Aviv Saurasky Medical Center, Tel Aviv

Asaf Harofeh Medical Center, Zrifin

Spedali Civili di Brescia, Brescia

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

A.O. San Paolo, Milan

"A.O. U. Federico II di Napoli", Napoli

"Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli", Napoli

Azienda Ospidaliera Universitaria Seconda Universita di Napoli, Napoli

A.O.U. Maggiore della Carità, Novara

"Ospedale Cristo Re dell'Istituto Figlie di N.S. al Monte Calvario", Roma

Fondazione Policlinico di Tor Vergata, Roma

Ospedale San Camillo, Roma

Policlinico A. Gemelli, Roma

Policlinico Umberto I Di Roma, Roma

Policlinico Univestitario Campus Biomedico, Roma

Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Kaunas

Klaipeda University Hospital, Klaipėda

Vilinius University Hospital Santariskiu Klinikos, Vilnius

Unidad de Hígado Hospital Universitario Dr. José Eleuterio González, Monterrey

JM Research, Cuernavaca

Consultorio Médico, Metepec

Consultorio Medico del Dr. Mauricio Castillo Barradas, Mexico City

Consultorio Medico, Mexico City

Instituto de Ciencias Medicas y de la Nutricion Salvador Zubiran, Mexico City

Torre de Consultorios Clinica Londres, Mexico City

Accelerium Clinical Research, Monterrey

"Angeles Valle oriente Hospital", San Pedro Garza García

Clinical Institute Colentina, Bucharest

"The National Institute for Infectious Diseases Prof. Dr. Matei Bals, Clinical Department for Adults II", Bucharest

County Hospital Mures-Gastroenterology Department, Târgu Mureş

06700

Torre de Consultorios Clinica Londres, Mexico City

All Listed Sponsors
collaborator

Sharp

INDUSTRY

collaborator

Diamond Pharma Services Regulatory Affairs Consultancy

OTHER

collaborator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

collaborator

ClinIntel

INDUSTRY

collaborator

Itamar-Medical, Israel

INDUSTRY

collaborator

One Way Liver OWL

INDUSTRY

collaborator

Medical University of Graz

OTHER

collaborator

Tel-Aviv Sourasky Medical Center

OTHER_GOV

collaborator

DSG EDC

UNKNOWN

collaborator

TransPerfect

INDUSTRY

collaborator

Clinical Reference Laboratory

INDUSTRY

lead

Galmed Research and Development, Ltd.

INDUSTRY