RecruitingNCT05621733

A PMS of Jakavi® in Patients With Steroid-Refractory Graft-versus-Host Disease (SR-GvHD) in Korea

A Post Marketing Surveillance of Jakavi® (Ruxolitinib) in Patients With Steroid-Refractory Graft-versus-Host Disease (SR-GvHD) in Korea


Sponsor

Novartis Pharmaceuticals

Enrollment

127 participants

Start Date

Apr 7, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

This study is a prospective, open-label, multi-center, non-comparative, observational study to assess safety and effectiveness of Jakavi® (ruxolitinib) in the real-world clinical setting in Korean Graft-versus-Host disease (GvHD) patients


Eligibility

Min Age: 12 YearsMax Age: 100 Years

Inclusion Criteria2

  • Patients who diagnosed with GvHD and currently receiving or going to receive Jakavi® treatment according to locally approved label
  • Patients who are willing to provide written informed consent prior to study enrollment

Exclusion Criteria3

  • Patients under 12 years old
  • Patients with contraindication according to locally approved label of Jakavi®
  • Patients who receive or are going to receive any investigational medicine during the observation period.

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Interventions

OTHERruxolitinib

Prospective observational study. There is no treatment allocation. Patients prescribed with ruxolitinib in the commercial setting are eligible to enroll into this study.


Locations(11)

Novartis Investigative Site

Daegu, Dalseo gu, South Korea

Novartis Investigative Site

Wŏnju, Gangwon-do, South Korea

Novartis Investigative Site

Seoul, Seocho gu, South Korea

Novartis Investigative Site

Busan, South Korea

Novartis Investigative Site

Busan, South Korea

Novartis Investigative Site

Busan, South Korea

Novartis Investigative Site

Jeollanam, South Korea

Novartis Investigative Site

Jinju, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Taegu, South Korea

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NCT05621733


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