An observational study in Hemoglobinuria and Paroxysmal, sponsored by Yonsei University. Enrolling by invitation at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Yonsei University · Observational
This multicenter, retrospective observational cohort study aims to evaluate the long-term real-world effectiveness and safety of ravulizumab in adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) in South Korea over a 4-year post-marketing period. By analyzing electronic medical records (EMR) from participating institutions, the study investigates intravascular hemolysis control, transfusion avoidance, breakthrough hemolysis (BTH) characteristics, and overall clinical outcomes in an Asian population.
14 studies on the registry are indexed under Hemoglobinuria; 2 are open to participants now.
Browse Hemoglobinuria studies →Yonsei University is the lead sponsor of 1,418 studies on the registry; 241 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Korean patients with Paroxysmal Nocturnal Hemoglobinuria whose retrospective clinical data are available in the electronic medical records (EMR) of the participating hospitals.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients diagnosed with PNH and prescribed Ravulizumab at multiple centers in South Korea, whose electronic medical records (EMR) are available for retrospective review.
Proportion of patients achieving lactate dehydrogenase (LDH) levels less than or equal to 1.5 times the upper limit of normal (ULN)
Assessment of intravascular hemolysis control, defined as achieving and maintaining serum LDH levels at or below 1.5 times the ULN during the 4-year post-marketing observation period.
Time frame: Up to 4 years after ravulizumab initiation
Incidence and clinical characteristics of breakthrough hemolysis (BTH)
BTH is defined as at least one new or worsening symptom or sign of intravascular hemolysis (fatigue, hemoglobinuria, abdominal pain, dyspnea, anemia \[hemoglobin less than 10 g/dL\], major adverse vascular events \[MAVE, including thrombosis\], dysphagia, or erectile dysfunction) in the presence of elevated lactate dehydrogenase (LDH) levels of at least 2 times the upper limit of normal (ULN), after prior reduction of LDH to less than 1.5 times the ULN during therapy. Associated contextual factors, including complement-amplifying conditions, hospitalizations, transfusions, and the use of rescue medication, will also be recorded and characterized at each event.
Time frame: hroughout the follow-up period, assessed at each occurrence of a BTH event (up to 4 years)
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Dec 2026, 4 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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