Survey on the use of Revolade tablets in children with aplastic anemia
Revolade Tablets Specified Drug-use Survey (Pediatric Aplastic Anemia Naive to Treatment With Anti-thymocyte Immunoglobulin, CETB115G1401)
This study is testing if Revolade tablets are safe and effective for children aged 6 to 17 with aplastic anemia who haven't received certain treatments yet.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Locations | 17 sites (Nagoya, Aichi-ken and 16 other locations) |
| Trial ID | NCT06287268 on ClinicalTrials.gov |
What this trial studies
This multicenter, single-arm observational survey aims to confirm the safety and efficacy of eltrombopag in pediatric patients aged 6 to 17 years who are treatment naive to Anti-Thymocyte Globulin (ATG) and diagnosed with aplastic anemia. The study will monitor participants for one year from the start of eltrombopag treatment, assessing outcomes regardless of whether treatment continues or if hematopoietic stem cell transplantation occurs. The administration of eltrombopag will follow the guidelines specified in the product's package insert.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 6 to 17 years with aplastic anemia who are receiving eltrombopag for the first time in combination with ATG.
Not a fit: Patients with congenital aplastic anemia or those who have previously received ATG without eltrombopag will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and efficacy of eltrombopag for treating pediatric patients with aplastic anemia.
How similar studies have performed: While this approach is observational, similar studies have shown promise in evaluating the efficacy of eltrombopag in other populations, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Nagoya, Aichi-ken and 16 other locations
- Novartis Investigative Site — Nagoya, Aichi-ken, Japan (Recruiting)
- Novartis Investigative Site — Nagoya, Aichi-ken, Japan (Recruiting)
- Novartis Investigative Site — Toyoake, Aichi-ken, Japan (Recruiting)
- Novartis Investigative Site — Chiba, Chiba, Japan (Recruiting)
- Novartis Investigative Site — Amagasaki, Hyōgo, Japan (Recruiting)
- Novartis Investigative Site — Kobe, Hyōgo, Japan (Recruiting)
- Novartis Investigative Site — Matsumoto, Nagano, Japan (Recruiting)
- Novartis Investigative Site — Shimajiri-Gun, Okinawa, Japan (Recruiting)
- Novartis Investigative Site — Izumi, Osaka, Japan (Recruiting)
- Novartis Investigative Site — Osaka, Osaka, Japan (Recruiting)
- Novartis Investigative Site — Sakai, Osaka, Japan (Recruiting)
- Novartis Investigative Site — Saitama, Saitama, Japan (Recruiting)
- Novartis Investigative Site — Ohtsu, Shiga, Japan (Recruiting)
- Novartis Investigative Site — Chuo Ku, Tokyo, Japan (Recruiting)
- Novartis Investigative Site — Ōta-ku, Tokyo, Japan (Recruiting)
- Novartis Investigative Site — Setagaya-ku, Tokyo, Japan (Recruiting)
- Novartis Investigative Site — Wakayama, Wakayama, Japan (Recruiting)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +81337978748
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.