Survey on the use of Revolade tablets in children with aplastic anemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +81337978748

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Isatuximab in adults with refractory severe aplastic anemia

  This study tests whether the drug isatuximab can help adults with refractory severe aplastic anemia who have very low blood counts.

  Recruiting Phase 1/2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT07714512

• Brain network changes in adults with anemia measured by fNIRS

  This project will use functional near-infrared spectroscopy (fNIRS) to see if brain network connections are altered in adults aged 18–65 who have anemia.

  Recruiting Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT07578675

• Daratumumab for refractory aplastic anemia in adults

  This trial tests whether daratumumab can be safely given and help people with refractory aplastic anemia see a benefit.

  Recruiting Phase 1/2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT07287228

• High-altitude stem cell and bone marrow transplant registry on the Qinghai-Tibet Plateau

  This project will collect clinical data and blood/bone marrow samples from people having hematopoietic stem cell transplants on the Qinghai‑Tibet Plateau to see how high altitude affects transplant outcomes and recovery.

  Recruiting Affiliated Hospital of Qinghai University · Xining, Qinghai · NCT07205523

• Predicting pregnancy risks for women with aplastic anemia

  This project will try to create a model to predict which pregnant women with aplastic anemia are most likely to have maternal or newborn complications.

  Recruiting Peking University People's Hospital · Beijing · NCT07101770

• Impact of Aplastic Anemia on Reproductive and Mental Health

  This study looks at how aplastic anemia and its treatments affect the reproductive and mental health of young adults aged 18-40.

  Recruiting Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT06936930

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.