Danicopan PMS in Korea
Danicopan Regulatory Post-Marketing Study in Korea
1 other identifier
observational
8
1 country
4
Brief Summary
As part of a post-approval commitment, the Korean health authority requests a study to characterize safety and effectiveness in patients who are treated with Danicopan as an add-on to ravulizumab or eculizumab in normal clinical practice settings. This study is designed to assess the known safety profile or identify previously unsuspected adverse reactions and to evaluate the effectiveness of Danicopan under conditions of routine daily medical practice in Korea.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2026
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2026
CompletedFirst Posted
Study publicly available on registry
March 9, 2026
CompletedStudy Start
First participant enrolled
April 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 27, 2028
April 17, 2026
April 1, 2026
2.2 years
February 13, 2026
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs), AESI
To assess the safety of Danicopan as add-on therapy to a C5 inhibitor (Eculizumab or Ravulizumab)in patients with PNH in Korea.
Patient data will be gathered for up to 12 weeks from the first dose of the study drug.
Secondary Outcomes (4)
Change from baseline in hemoglobin (Hgb) at Week 12
Effectiveness variables will be assessed at Week 12 or end of treatment (if treatment is discontinued before Week 12).
Change from baseline in absolute reticulocyte count (ARC) at Week 12
Effectiveness variables will be assessed at Week 12 orend of treatment (if treatment is discontinued before Week 12)
Change from baseline in FACIT Fatigue scores at Week 12
Effectiveness variables will be assessed at Week 12 orend of treatment (if treatment is discontinued before Week 12)
Proportion of patients with transfusion avoidance* at Week 12(* Transfusion Avoidance: Defined as remaining free from red blood cell transfusions)
Effectiveness variables will be assessed at Week 12 orend of treatment (if treatment is discontinued before Week 12)
Eligibility Criteria
Patients currently treated with or initiating the study drug under approved local label and conditions of routine daily medical practice in Korea will be included in the study. This study will be conducted using a total surveillance method to investigate the safety and effectiveness of all patients being treated with the study drug.
You may qualify if:
- Patients eligible for and treated with Danicpan as add-on therapy to a C5 inhibitor (Eculizumab or Ravulizumab) in patient with PNH in Korea
- Provision of a signed and dated written informed consent by the patient or their legally acceptable representative
You may not qualify if:
- Participation in any concurrent interventional trials during the period of study drug treatment
- Other off-label indications according to the approved label in Korea
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (4)
Research Site
Busan, South Korea
Research Site
Daegu, South Korea
Research Site
Hwasun-gun, South Korea
Research Site
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2026
First Posted
March 9, 2026
Study Start
April 10, 2026
Primary Completion (Estimated)
June 27, 2028
Study Completion (Estimated)
June 27, 2028
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.