Revolade Tablets Specified Drug-use Survey

Launched by NOVARTIS PHARMACEUTICALS · Feb 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called eltrombopag in children and teenagers with aplastic anemia (AA), a condition where the body doesn’t make enough blood cells. The trial aims to see if eltrombopag is safe and effective when given for the first time along with another treatment called Anti-Thymocyte Globulin (ATG). This study is open to young patients aged 6 to 17 years who have never received ATG before.

To participate, a child must have permission from a parent or guardian and meet certain conditions, such as being diagnosed with AA and not having received ATG previously. During the trial, participants will take eltrombopag and be monitored for their health and response to the treatment. It’s important to know that children with certain other blood disorders or who have received similar medications before won't be eligible. This study is currently recruiting participants, and it hopes to provide helpful information for treating pediatric patients with aplastic anemia.

Gender

ALL

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)