RecruitingPhase 3NCT05005975

Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects With Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)

A Phase 3, Multicenter, Open-label, Long-term, Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects With Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)

Sponsor

Tanabe Pharma America, Inc.

Enrollment

301 participants

Start Date

Aug 10, 2021

Study Type

INTERVENTIONAL

Conditions

EPP XLP

Summary

To evaluate the long-term safety and tolerability of oral dersimelagon.

Eligibility

Min Age: 12 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called MT-7117 for people with epp and xlp. The study is currently recruiting participants at 45 locations. People eligible for this study include aged 12 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMT-7117

MT-7117

Locations(45)

Marvel Clinical Research, LLC

Huntington Beach, California, United States

University of California at San Francisco - CSF Porphyria Center

San Francisco, California, United States

University Of Miami School Of Medicine, Center For Liver Diseases

Miami, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

MetroBoston Clinical Partners, LLC

Brighton, Massachusetts, United States

Henry Ford Health System

Detroit, Michigan, United States

Kansas City Research Institute

Kansas City, Missouri, United States

Icahn School of Medicine at Mount Sinai (ISSMS)-The Mount Sinai Hospital (MSH)

New York, New York, United States

Wake Forest University Baptist Health

Winston-Salem, North Carolina, United States

Remington-Davis Clinical Research

Columbus, Ohio, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

The University of Texas Medical Branch (UTMB)

Galveston, Texas, United States

University of Washington-Seattle Cancer Care Alliance

Seattle, Washington, United States

Wesley Medical Research

Brisbane, Queensland, Australia

Royal Melbourne Hospital (RMH)

Parkville, Victoria, Australia

University Multi-Profile Hospital for Active Treatment (UMHAT) St. Ivan Rilski

Sofia, Bulgaria

University of Alberta Hospital

Edmonton, Alberta, Canada

Institute for Clinical and Experimental Medicine - IKEM

Prague, Czechia

Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre

Bordeaux, France

Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Louis-Mourier

Colombes, France

CHU Nantes

Nantes, France

Hospital Bichat-Hopitaux Universitaires Paris Nord Val de Seine

Paris, France

Charite - Universitaetsmedizin Berlin

Berlin, Germany

I.F.O. Hospital, Centro Porfirie e Malattie Rare

Roma, Rome, Italy

Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia

Brescia BS, Italy

Azienda Sanitaria Ospedaliera Santa Croce E Carle - Cuneo

Cuneo CN, Italy

Ospedalle Galliera

Genova GE, Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano

Milan, Italy

U.O.C. Medicina Interna Azienda ospedaliero Universitaria Policlinico di Modena

Modena, Italy

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Materno-Infantile - Burlo Garofolo - Clinica Pediatrica

Trieste TS, Italy

Kobe University Hospital

Kobe, Hyōgo, Japan

Sophia Dermatology Clinic

Kanazawa, Ishikawa-ken, Japan

Osaka Medical College Hospital

Takatsuki, Osaka, Japan

Tokyo Saiseikai Central Hospital

Minato-ku, Tokyo, Japan

Toyama University Hospital

Sugitani, Toyama, Japan

Hamamatsu University Hospital

Shizuoka, Japan

Erasmus MC, Universitair Medisch Centrum Rotterdam

Rotterdam, Netherlands

Haukeland University Hospital

Bergen, Norway

Instytut hematologii i Transfuzjologii

Warsaw, Poland

Hospital Clínic de Barcelona

Barcelona, Spain

Hospital Universitario

Madrid, Spain

Hospital General Universitario De Valencia

Valencia, Spain

Karolinska University Hospital

Stockholm, Sweden

Salford Royal NHS Foundation Trust

Manchester, MN, United Kingdom

St. John's Institute of Dermatology-Guy's & St Thomas' NHS Foundation Trust

London, United Kingdom

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NCT05005975