Revolade Tablets Specified Drug-use Survey

Last updated: February 18, 2026
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anemia

Red Blood Cell Disorders

Aplastic Anemia

Treatment

eltrombopag

Clinical Study ID

NCT06287268
CETB115G1401
  • Ages 6-17
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients whose legally acceptable representative has given written consent forcooperation 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 combinationwith ATG after the approval of additional dosage and administration for "ATG-naïvepediatric patients with AA"

Exclusion

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) atthe start of treatment with eltrombopag

  • Patients who have received any drug products containing the same ingredient aseltrombopag (including investigational products)

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: eltrombopag
Phase:
Study Start date:
July 17, 2024
Estimated Completion Date:
October 31, 2028

Study 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.

Connect with a study center

  • Novartis Investigative Site

    Nagoya, Aichi 466 8560
    Japan

    Site Not Available

  • Novartis Investigative Site

    Toyoake city, Aichi 470 1192
    Japan

    Site Not Available

  • Novartis Investigative Site

    Nagoya 1856057, Aichi-ken 1865694 453-8511
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Toyoake 6822210, Aichi-ken 1865694 4701192
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Chiba 2113015, Chiba 2113014 260 8677
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Amagasaki city, Hyogo 660 8550
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kobe, Hyogo 650-0047
    Japan

    Site Not Available

  • Novartis Investigative Site

    Amagasaki 1865387, Hyōgo 1862047 660 8550
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Kobe 1859171, Hyōgo 1862047 6500047
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Matsumoto, Nagano 390-8621
    Japan

    Site Not Available

  • Novartis Investigative Site

    Matsumoto 1857519, Nagano 1856210 3908621
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Shimajiri-Gun, Okinawa 1854345 901-1303
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Izumi-city, Osaka 594-1101
    Japan

    Site Not Available

  • Novartis Investigative Site

    Osaka Sayama, Osaka 589 8511
    Japan

    Site Not Available

  • Novartis Investigative Site

    Izumi 1861107, Osaka 1853904 5941101
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Osaka 1853909, Osaka 1853904 5340021
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Sakai 1853195, Osaka 1853904 590-0197
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Saitama 6940394, Saitama 1853226 3308777
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Ohtsu, Shiga 1852553 5202192
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Chuo ku, Tokyo 104 8560
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Ota-ku, Tokyo 143 8541
    Japan

    Site Not Available

  • Novartis Investigative Site

    Chuo Ku, Tokyo 1850144 1048560
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Setagaya-ku, Tokyo 1850144 1578535
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Ōta-ku 8469289, Tokyo 1850144 143 8541
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Wakayama 1926004, Wakayama 1848938 641-8510
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Osaka, 534-0021
    Japan

    Site Not Available

  • Novartis Investigative Site

    Saitama, 330 8777
    Japan

    Site Not Available

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