Long-term safety and tolerability of MY008211A tablets for patients with PNH

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, single-arm, open-label study aims to evaluate the long-term safety, tolerability, and efficacy of MY008211A tablets in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). It provides continued access to MY008211A for patients who have previously completed Phase 2 or 3 studies and have shown benefit from the treatment. The study will monitor participants for any adverse effects and assess the overall effectiveness of the medication over an extended period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Chinese Academy of Medical Sciences Hematology Hospital (Institute of Hematology, Chinese Academy of Medical Sciences)
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Wuhan Createrna Science and Technology Co.,Ltd
• Email: lcyxzx@createrna.com
• Phone: 027-68788900

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.