Revolade Tablets Specified Drug-use Survey
1 other identifier
observational
10
1 country
17
Brief 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).
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 Jul 2024
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2024
CompletedFirst Posted
Study publicly available on registry
March 1, 2024
CompletedStudy Start
First participant enrolled
July 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2028
February 19, 2026
February 1, 2026
4.3 years
February 22, 2024
February 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of serious adverse events
Occurrence of serious adverse events to be provided
Up to 1 year
Secondary Outcomes (10)
Occurrence of adverse events and adverse drug reactions leading to treatment discontinuation
Up to 1 Year
Occurrence of adverse events and adverse drug reactions applicable to safety specifications (hepatic dysfunction and hematopoietic malignancies)
Up to 1 year
Occurrence of clonal evolution
Up to 1 year
Hematologic response status
Up to 1 year
Change over time from baseline in platelet count
Baseline, 1 year
- +5 more secondary outcomes
Study Arms (1)
eltrombopag
ATG treatment naïve pediatric patients with AA in routine clinical practice
Interventions
This is an observational study. There is no treatment allocation. After confirming that patients are fulfilling the eligibility criteria, patients will be registered in this survey.
Eligibility Criteria
The survey will be conducted in pediatric patients with Aplastic anemia (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."
You may qualify if:
- 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"
You may not qualify if:
- Patients who have received ATG without concomitant use of eltrombopag
- Patients with congenital AA
- Patients with suspected or confirmed diagnosis of myelodysplastic syndrome (MDS) at the start of treatment with eltrombopag
- Patients who have received any drug products containing the same ingredient as eltrombopag (including investigational products)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Novartis Investigative Site
Nagoya, Aichi-ken, 453-8511, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, 4668560, Japan
Novartis Investigative Site
Toyoake, Aichi-ken, 4701192, Japan
Novartis Investigative Site
Chiba, Chiba, 260 8677, Japan
Novartis Investigative Site
Amagasaki, Hyōgo, 660 8550, Japan
Novartis Investigative Site
Kobe, Hyōgo, 6500047, Japan
Novartis Investigative Site
Matsumoto, Nagano, 3908621, Japan
Novartis Investigative Site
Shimajiri-Gun, Okinawa, 901-1303, Japan
Novartis Investigative Site
Izumi, Osaka, 5941101, Japan
Novartis Investigative Site
Osaka, Osaka, 5340021, Japan
Novartis Investigative Site
Sakai, Osaka, 590-0197, Japan
Novartis Investigative Site
Saitama, Saitama, 3308777, Japan
Novartis Investigative Site
Ohtsu, Shiga, 5202192, Japan
Novartis Investigative Site
Chuo Ku, Tokyo, 1048560, Japan
Novartis Investigative Site
Ōta-ku, Tokyo, 143 8541, Japan
Novartis Investigative Site
Setagaya-ku, Tokyo, 1578535, Japan
Novartis Investigative Site
Wakayama, Wakayama, 641-8510, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Central Study Contacts
Novartis Pharmaceuticals
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2024
First Posted
March 1, 2024
Study Start
July 17, 2024
Primary Completion (Estimated)
October 31, 2028
Study Completion (Estimated)
October 31, 2028
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share