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NCT Number: NCT06287268

Revolade Tablets Specified Drug-use Survey

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).

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Key information

Conditions

Aplastic Anemia Anemia Anemia, Aplastic Bone Marrow Diseases Bone Marrow Failure Disorders Hematologic Diseases Hemic and Lymphatic Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Nagoya, Aichi-ken, Japan

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About this study

The objective of this survey is to confirm the safety and efficacy of eltrombopag in ATG treatment naive pediatric patients with AA. Eltrombopag should be administered according to the dosage and administration specified in the latest version of the package insert. The observation period is 1 year (364 days) from the start of treatment with this product, regardless of whether treatment with eltrombopag is continued or not. However, if hematopoietic stem cell transplantation is performed within 1 year after the start of treatment with eltrombopag, the observation period shall be until the date of hematopoietic stem cell transplantation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

eltrombopag

Other

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.

Primary outcomes

  1. Occurrence of serious adverse events

    Time frame: Up to 1 year

    Occurrence of serious adverse events to be provided

Secondary outcomes

  1. Occurrence of adverse events and adverse drug reactions leading to treatment discontinuation

    Time frame: Up to 1 Year

    Occurrence of adverse events and adverse drug reactions leading to treatment discontinuation to be provided

  2. Occurrence of adverse events and adverse drug reactions applicable to safety specifications (hepatic dysfunction and hematopoietic malignancies)

    Time frame: Up to 1 year

    Occurrence of adverse events and adverse drug reactions applicable to safety specifications (hepatic dysfunction and hematopoietic malignancies)

  3. Occurrence of clonal evolution

    Time frame: Up to 1 year

    Occurrence of clonal evolution [cytogenetic abnormalities, myelodysplastic syndrome (MDS), Acute Myeloid Leukemia (AML), and paroxysmal nocturnal hemoglobinuria (PNH)]

  4. Hematologic response status

    Time frame: Up to 1 year

    Hematologic response status to be provided

  5. Change over time from baseline in platelet count

    Time frame: Baseline, 1 year

    Change over time from baseline in platelet count to be provided

  6. Change over time from baseline in hemoglobin

    Time frame: Baseline, 1 year

    Change over time from baseline in hemoglobin to be provided

  7. Change over time from baseline in neutrophil count

    Time frame: Baseline, 1 year

    Change over time from baseline in neutrophil count to be provided

  8. Change over time from baseline in reticulocyte count

    Time frame: Baseline, 1 year

    Change over time from baseline in reticulocyte count to be provided

  9. Change over time from baseline in transfusion dependence

    Time frame: Baseline, 1 year

    Change over time from baseline in transfusion dependence to be provided

  10. Change over time from baseline in transfusion volume

    Time frame: Baseline, 1 year

    Change over time from baseline in transfusion volume to be provided

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+81337978748

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Revolade Tablets Specified Drug-use Survey (Pediatric Aplastic Anemia Naive to Treatment With Anti-thymocyte Immunoglobulin, CETB115G1401)

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 1, 2024
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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