An Open Label, Multicenter Study to Evaluate the Long-term Safety and Tolerability of MY008211A Tablets in Patients With PNH Paroxysmal Nocturnal Hemoglobinuria (PNH)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
This is a multicenter, single-arm, open-label study to characterize long-term safety and tolerability of MY008211A tablets and to provide access to MY008211A tablets to patients with PNH who have completed Phase 2 or 3 studies with MY008211A tablets.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients who have previously received and completed MY008211A study treatment, and are judged by the investigator to have treatment benefit and may benefit from continued treatment of MY008211A.
• Prior vaccinations against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections.
Locations
Other Locations
China
Chinese Academy of Medical Sciences Hematology Hospital (Institute of Hematology, Chinese Academy of Medical Sciences)
RECRUITING
Tianjin
Contact Information
Primary
Wuhan Createrna Science and Technology Co.,Ltd
lcyxzx@createrna.com
027-68788900
Time Frame
Start Date: 2024-11-30
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 120
Treatments
Experimental: MY008211A tablets
MY008211A tablets 400mg BID
Related Therapeutic Areas
Sponsors
Leads: Wuhan Createrna Science and Technology Co., Ltd