Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects With Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)
Part of paid clinical trials in Huntington Beach, California.
- Sponsor
- Tanabe Pharma America, Inc.
- Study ID
- NCT05005975
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- EPP
- XLP
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- MT-7117 — DRUGMT-7117
Study Details
To evaluate the long-term safety and tolerability of oral dersimelagon.
Key Dates
- Start date
- Aug 10, 2021
- Status verified
- Dec 2025
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 301 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Dersimelagon 200mg
Primary Outcome Measure
Number of patients with Treatment emergent adverse events (TEAEs) (including serious adverse events [SAEs] and adverse events of special interest [AESIs]). [ Time Frame: up to 66 further months ]
Central Contacts
- Clinical Trials Information Desk, To prevent mis-communication,please e-mail
Locations (15)
Find similar trials in Huntington Beach, CA
By research site
Marvel Clinical Research, LLC· Huntington Beach, CAUniversity of California at San Francisco - CSF Porphyria Center· San Francisco, CAUniversity Of Miami School Of Medicine, Center For Liver Diseases· Miami, FLMassachusetts General Hospital· Boston, MAMetroBoston Clinical Partners, LLC· Brighton, MAHenry Ford Health System· Detroit, MI