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Natural History Study of Adult Patients With Paroxysmal Nocturnal Hemoglobinuria of High-risk Hemolysis in China

NCT05125341 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 67

Last updated 2022-07-05

No results posted yet for this study

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

  • Paroxysmal Nocturnal Hemoglobinuria, Natural History Study

Sponsors & Collaborators

  • CARE Pharma Shanghai Ltd.

    lead INDUSTRY

Principal Investigators

  • Bing Han, MD · Peking Union Medical College Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-25
Primary Completion
2022-03-16
Completion
2022-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05125341 on ClinicalTrials.gov