Trials / Completed
CompletedNCT05125341
Natural History Study of Adult Patients With Paroxysmal Nocturnal Hemoglobinuria of High-risk Hemolysis in China
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 67 (actual)
- Sponsor
- CARE Pharma Shanghai Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
This is a single-center observational study conducted in adult patients with paroxysmal nocturnal hemoglobinuria of high-risk hemolysis. This observational study consists of two parts, one part is retrospective study which aims to collect medical chart data to calculate the mean change or mean incidence rates of LDH, hemoglobin, PNH-related symptoms and PNH-related events over 6 months. The other part is cross-sectional study to detect the total C5 level in PUMCH at the latest follow-up visit in eligible PNH patients with high-risk hemolysis, to show the difference between eligible PNH patients and healthy people and to explore the related clinical factor influencing high-level total C5 using logistic regression model.
Conditions
Timeline
- Start date
- 2021-11-25
- Primary completion
- 2022-03-16
- Completion
- 2022-04-30
- First posted
- 2021-11-18
- Last updated
- 2022-07-05
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05125341. Inclusion in this directory is not an endorsement.