NCT06933914 Long-term Safety and Tolerability of MY008211A Tablets in Patients With Paroxysmal Nocturnal Hemoglobinuria
| NCT ID | NCT06933914 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Wuhan Createrna Science and Technology Co., Ltd |
| Condition | Paroxysmal Nocturnal Hemoglobinuria (PNH) |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-11-30 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2024-11-30 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. 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. 2. Prior vaccinations against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections. Exclusion Criteria: 1. History of recurrent invasive infections caused by encapsulated organisms, e.g. meningococcus or pneumococcus. 2. Known or suspected hereditary complement deficiency. 3. Any comorbidity or medical condition (including but not limited to any active systemic bacterial, viral or fungal infection or malignancy) that, in the opinion of the investigator, could put the subject at increased risk or potentially confound study data.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06933914 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Paroxysmal Nocturnal Hemoglobinuria (PNH). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06933914 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06933914 currently recruiting?
Yes, NCT06933914 is actively recruiting participants. Contact the research team at lcyxzx@createrna.com for enrollment information.
Where is the NCT06933914 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06933914 clinical trial?
NCT06933914 is sponsored by Wuhan Createrna Science and Technology Co., Ltd. The trial plans to enroll 120 participants.