Trials / Completed
CompletedNCT06050226
A Study of MY008211A in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
A Multi-center, Randomized, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of MY008211A Tablets in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria and Active Hemolysis.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Wuhan Createrna Science and Technology Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The main purpose of this study is to evaluate the efficacy of MY008211A in adult patients with PNH , showing signs of active hemolysis, in China.
Detailed description
The purpose of this study is to determine whether MY008211A is efficacious and safe for the treatment of PNH patients who are naive to complement inhibitor therapy, including anti-C5 antibody.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MY008211A tablets | The first 10 participants will be received low-dose MY008211A tablets, and the next 30 participants will be randomized to low-dose or high-dose treatment arms in a 1:2 ratio. |
Timeline
- Start date
- 2023-07-06
- Primary completion
- 2024-04-30
- Completion
- 2024-11-28
- First posted
- 2023-09-22
- Last updated
- 2025-07-30
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06050226. Inclusion in this directory is not an endorsement.