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)

Tanabe Pharma America, Inc.

Summary

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

Eligibility

Age range: 12–75 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 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'…

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)

Summary

Eligibility

Interventions

Locations (51)