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Recruiting NCT06287268

Revolade Tablets Specified Drug-use Survey

— Observational Aplastic Anemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: eltrombopag.
Who it may be relevant to
Registry conditions: Aplastic Anemia. Basic parameters: 6 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Detailed description

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.

Interventions

  • Other eltrombopag
    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 outcome measures

  • Occurrence of serious adverse events [Time frame: Up to 1 year]
Secondary outcome measures (10)
  • 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 applicable to safety specifications (hepatic dysfunction and hematopoietic malignancies) [Time frame: Up to 1 year]
  • Occurrence of clonal evolution [Time frame: Up to 1 year]
  • Hematologic response status [Time frame: Up to 1 year]
  • Change over time from baseline in platelet count [Time frame: Baseline, 1 year]
  • Change over time from baseline in hemoglobin [Time frame: Baseline, 1 year]
  • Change over time from baseline in neutrophil count [Time frame: Baseline, 1 year]
  • Change over time from baseline in reticulocyte count [Time frame: Baseline, 1 year]
  • Change over time from baseline in transfusion dependence [Time frame: Baseline, 1 year]
  • Change over time from baseline in transfusion volume [Time frame: Baseline, 1 year]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Japan · 17 centers
  • Novartis Investigative Site — Nagoya
  • Novartis Investigative Site — Nagoya
  • Novartis Investigative Site — Toyoake
  • Novartis Investigative Site — Chiba
  • Novartis Investigative Site — Amagasaki
  • Novartis Investigative Site — Kobe
  • Novartis Investigative Site — Matsumoto
  • Novartis Investigative Site — Shimajiri-Gun
  • … and 9 more centers

Identifiers

NCT: NCT06287268 · CETB115G1401

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗