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)
Who is this study for? Patients with Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)
What treatments are being studied? MT-7117
Status: Recruiting
Location: See all (44) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
To evaluate the long-term safety and tolerability of oral dersimelagon.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 75
Healthy Volunteers: f
View:
⁃ Additional screening criteria check may apply for qualification:
• 1\. Subjects provided written informed consent to participate. For adolescent subjects, both adolescent assent and parental consent will be provided.
• 2\. Subjects who have completed: MT-7117-G01 (completed through Week 58 \[Visit 12\]) or, MT-7117-A-302 (completed through Week 58 \[Visit 10\]) or, MT-7117-A-301 (completed EOT - Week 104 or Week 130) according to protocol amendment 1 or 2.
• 3\. Subjects are willing and able to travel to the study sites for all scheduled visits.
• 4\. In the Investigator's opinion, subject can understand the nature of the study and any risks involved in participation, and is willing to cooperate and comply with the protocol restrictions and requirements (including travel).
• 5\. Female subjects who are non-lactating and have a negative urine pregnancy test at baseline visit prior to receiving the first dose of study drug.
• 6\. Female subjects of childbearing potential and male subjects with partner of childbearing potential must agree to use 2 effective methods of contraception including barrier method (especially for female subjects, one method must be highly effective method)
Locations
United States
California
Marvel Clinical Research, LLC
ACTIVE_NOT_RECRUITING
Huntington Beach
University of California at San Francisco - CSF Porphyria Center
ACTIVE_NOT_RECRUITING
San Francisco
Florida
University Of Miami School Of Medicine, Center For Liver Diseases
ACTIVE_NOT_RECRUITING
Miami
Massachusetts
Massachusetts General Hospital
ACTIVE_NOT_RECRUITING
Boston
MetroBoston Clinical Partners, LLC
ACTIVE_NOT_RECRUITING
Brighton
Michigan
Henry Ford Health System
ACTIVE_NOT_RECRUITING
Detroit
Missouri
Kansas City Research Institute
ACTIVE_NOT_RECRUITING
Kansas City
North Carolina
Wake Forest University Baptist Health
ACTIVE_NOT_RECRUITING
Winston-salem
New York
Icahn School of Medicine at Mount Sinai (ISSMS)-The Mount Sinai Hospital (MSH)
ACTIVE_NOT_RECRUITING
New York
Ohio
Remington-Davis Clinical Research
ACTIVE_NOT_RECRUITING
Columbus
Pennsylvania
Thomas Jefferson University
ACTIVE_NOT_RECRUITING
Philadelphia
Texas
The University of Texas Medical Branch (UTMB)
ACTIVE_NOT_RECRUITING
Galveston
Washington
University of Washington-Seattle Cancer Care Alliance
RECRUITING
Seattle
Other Locations
Australia
Wesley Medical Research
ACTIVE_NOT_RECRUITING
Brisbane
Royal Melbourne Hospital (RMH)
ACTIVE_NOT_RECRUITING
Parkville
Bulgaria
University Multi-Profile Hospital for Active Treatment (UMHAT) St. Ivan Rilski
ACTIVE_NOT_RECRUITING
Sofia
Canada
University of Alberta Hospital
ACTIVE_NOT_RECRUITING
Edmonton
France
Centre Hospitalier Universitaire de Bordeaux - Hopital Saint - Andre
ACTIVE_NOT_RECRUITING
Bordeaux
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Louis-Mourier
ACTIVE_NOT_RECRUITING
Colombes
CHU Nantes
ACTIVE_NOT_RECRUITING
Nantes
Hospital Bichat-Hopitaux Universitaires Paris Nord Val de Seine
ACTIVE_NOT_RECRUITING
Paris
Germany
Charite - Universitaetsmedizin Berlin
ACTIVE_NOT_RECRUITING
Berlin
Italy
Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia
ACTIVE_NOT_RECRUITING
Brescia Bs
Azienda Sanitaria Ospedaliera Santa Croce E Carle - Cuneo
ACTIVE_NOT_RECRUITING
Cuneo Cn
Ospedalle Galliera
ACTIVE_NOT_RECRUITING
Genova Ge
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano
ACTIVE_NOT_RECRUITING
Milan
U.O.C. Medicina Interna Azienda ospedaliero Universitaria Policlinico di Modena
ACTIVE_NOT_RECRUITING
Modena
I.F.O. Hospital, Centro Porfirie e Malattie Rare
ACTIVE_NOT_RECRUITING
Roma
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Materno-Infantile - Burlo Garofolo - Clinica Pediatrica
ACTIVE_NOT_RECRUITING
Trieste Ts
Japan
Sophia Dermatology Clinic
ACTIVE_NOT_RECRUITING
Kanazawa
Kobe University Hospital
ACTIVE_NOT_RECRUITING
Kobe
Tokyo Saiseikai Central Hospital
ACTIVE_NOT_RECRUITING
Minato-ku
Hamamatsu University Hospital
ACTIVE_NOT_RECRUITING
Shizuoka
Toyama University Hospital
ACTIVE_NOT_RECRUITING
Sugitani
Osaka Medical College Hospital
ACTIVE_NOT_RECRUITING
Takatsuki
Netherlands
Erasmus MC, Universitair Medisch Centrum Rotterdam
ACTIVE_NOT_RECRUITING
Rotterdam
Norway
Haukeland University Hospital
ACTIVE_NOT_RECRUITING
Bergen
Poland
Instytut hematologii i Transfuzjologii
ACTIVE_NOT_RECRUITING
Warsaw
Spain
Hospital Clínic de Barcelona
ACTIVE_NOT_RECRUITING
Barcelona
Hospital Universitario
ACTIVE_NOT_RECRUITING
Madrid
Hospital General Universitario De Valencia
ACTIVE_NOT_RECRUITING
Valencia
Sweden
Karolinska University Hospital
ACTIVE_NOT_RECRUITING
Stockholm
United Kingdom
St. John's Institute of Dermatology-Guy's & St Thomas' NHS Foundation Trust
ACTIVE_NOT_RECRUITING
London
Salford Royal NHS Foundation Trust
ACTIVE_NOT_RECRUITING
Manchester
Contact Information
Primary
Clinical Trials Information Desk, To prevent mis-communication,