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Danicopan PMS in Korea
Danicopan PMS in Korea

NCT07457151

RecruitingN/A

Sponsor: AstraZeneca

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Countries: South Korea

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.

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

1. Patients eligible for and treated with Danicpan as add-on therapy to a C5 inhibitor (Eculizumab or Ravulizumab) in patient with PNH in Korea
2. Provision of a signed and dated written informed consent by the patient or their legally acceptable representative

Exclusion Criteria:

1. Participation in any concurrent interventional trials during the period of study drug treatment
2. Other off-label indications according to the approved label in Korea
Locations (4)
  • Busan, South Korea
  • Hwasun-gun, South Korea
  • Seoul, South Korea
  • Seoul, South Korea