Revolade Tablets Specified Drug-use Survey (Pediatric Aplastic Anemia Naive to Treatment With Anti-thymocyte Immunoglobulin, CETB115G1401)
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY
This is a multicenter, single-arm, non-interventional study (NIS) to confirm the safety and efficacy of eltrombopag in Anti-Thymocyte Globulin (ATG) treatment naive pediatric patients with aplastic anemia (AA).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 17
Healthy Volunteers: f
View:
• Patients whose legally acceptable representative has given written consent for cooperation in this survey prior to enrollment in this survey
• Patients aged ≥ 6 years and \< 18 years at the start of treatment with eltrombopag
• Pediatric patients with AA who receive eltrombopag for the first time in combination with ATG after the approval of additional dosage and administration for ATG-naïve pediatric patients with AA
Locations
Other Locations
Japan
Novartis Investigative Site
RECRUITING
Amagasaki
Novartis Investigative Site
RECRUITING
Chuo Ku
Novartis Investigative Site
RECRUITING
Izumi
Novartis Investigative Site
RECRUITING
Kobe
Novartis Investigative Site
RECRUITING
Matsumoto
Novartis Investigative Site
RECRUITING
Nagoya
Novartis Investigative Site
RECRUITING
Nagoya
Novartis Investigative Site
RECRUITING
Ohtsu
Novartis Investigative Site
RECRUITING
Osaka
Novartis Investigative Site
RECRUITING
Ōsaka-sayama
Novartis Investigative Site
RECRUITING
Ōta-ku
Novartis Investigative Site
RECRUITING
Saitama
Novartis Investigative Site
RECRUITING
Setagaya-ku
Novartis Investigative Site
RECRUITING
Shimajiri-gun
Novartis Investigative Site
RECRUITING
Toyoake
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
+81337978748
Backup
Novartis Pharmaceuticals
Time Frame
Start Date: 2024-07-17
Estimated Completion Date: 2029-03-28
Participants
Target number of participants: 10
Treatments
eltrombopag
ATG treatment naïve pediatric patients with AA in routine clinical practice
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals