Long-term Safety and Tolerability of MY008211A Tablets in Patients With Paroxysmal Nocturnal Hemoglobinuria

Last updated: April 11, 2025
Sponsor: Wuhan Createrna Science and Technology Co., Ltd
Overall Status: Active - Recruiting

Phase

2/3

Condition

Anemia

Hemoglobinuria, Paroxysmal

Proteinuria

Treatment

MY008211A tablets

Clinical Study ID

NCT06933914
MY008211A-PNH-2-03
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  1. Patients who have previously received and completed MY008211A study treatment, andare judged by the investigator to have treatment benefit and may benefit fromcontinued treatment of MY008211A.

  2. Prior vaccinations against Neisseria meningitidis, Streptococcus pneumoniae andHaemophilus influenzae infections.

Exclusion

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 activesystemic bacterial, viral or fungal infection or malignancy) that, in the opinion ofthe investigator, could put the subject at increased risk or potentially confoundstudy data.

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: MY008211A tablets
Phase: 2/3
Study Start date:
November 30, 2024
Estimated Completion Date:
December 30, 2026

Study Description

The purpose of this open-label, single arm, multicenter study is to evaluate the long-term safety, tolerability and efficacy of MY008211A tablets in patients with PNH and to provide access to patients who have completed (without tapering down) Phase 2 and Phase 3 trials and derived benefit from MY008211A treatment.

Connect with a study center

  • Chinese Academy of Medical Sciences Hematology Hospital (Institute of Hematology, Chinese Academy of Medical Sciences)

    Tianjin, Tianjin 300020
    China

    Active - Recruiting

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