NCT06287268 Revolade Tablets Specified Drug-use Survey
| NCT ID | NCT06287268 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Aplastic Anemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-07-17 |
| Primary Completion | 2028-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10 participants in total. It began in 2024-07-17 with a primary completion date of 2028-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
Inclusion Criteria: * 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" Exclusion Criteria: * 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 & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT06287268 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 17 Years, studying Aplastic Anemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06287268 currently recruiting?
Yes, NCT06287268 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT06287268 trial being conducted?
This trial is being conducted at Nagoya, Japan, Nagoya, Japan, Toyoake, Japan, Chiba, Japan and 11 additional locations.
Who is sponsoring the NCT06287268 clinical trial?
NCT06287268 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 10 participants.