Revolade Tablets Specified Drug-use Survey

February 18, 2026 updated by: Novartis Pharmaceuticals

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Novartis Pharmaceuticals

Study Contact Backup

Study Locations

  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 453-8511
        • Recruiting
        • Novartis Investigative Site
      • Nagoya, Aichi-ken, Japan, 4668560
        • Recruiting
        • Novartis Investigative Site
      • Toyoake, Aichi-ken, Japan, 4701192
        • Recruiting
        • Novartis Investigative Site
    • Chiba
      • Chiba, Chiba, Japan, 260 8677
        • Recruiting
        • Novartis Investigative Site
    • Hyōgo
      • Amagasaki, Hyōgo, Japan, 660 8550
        • Recruiting
        • Novartis Investigative Site
      • Kobe, Hyōgo, Japan, 6500047
        • Recruiting
        • Novartis Investigative Site
    • Nagano
      • Matsumoto, Nagano, Japan, 3908621
        • Recruiting
        • Novartis Investigative Site
    • Okinawa
      • Shimajiri-Gun, Okinawa, Japan, 901-1303
        • Recruiting
        • Novartis Investigative Site
    • Osaka
      • Izumi, Osaka, Japan, 5941101
        • Recruiting
        • Novartis Investigative Site
      • Osaka, Osaka, Japan, 5340021
        • Recruiting
        • Novartis Investigative Site
      • Sakai, Osaka, Japan, 590-0197
        • Recruiting
        • Novartis Investigative Site
    • Saitama
      • Saitama, Saitama, Japan, 3308777
        • Recruiting
        • Novartis Investigative Site
    • Shiga
      • Ohtsu, Shiga, Japan, 5202192
        • Recruiting
        • Novartis Investigative Site
    • Tokyo
      • Chuo Ku, Tokyo, Japan, 1048560
        • Recruiting
        • Novartis Investigative Site
      • Setagaya-ku, Tokyo, Japan, 1578535
        • Recruiting
        • Novartis Investigative Site
      • Ōta-ku, Tokyo, Japan, 143 8541
        • Recruiting
        • Novartis Investigative Site
    • Wakayama
      • Wakayama, Wakayama, Japan, 641-8510
        • Recruiting
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The survey will be conducted in pediatric patients with Aplastic anemia (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."

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
eltrombopag
ATG treatment naïve pediatric patients with AA in routine clinical practice
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Occurrence of serious adverse events
Time Frame: Up to 1 year
Occurrence of serious adverse events to be provided
Up to 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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 adverse events and adverse drug reactions applicable to safety specifications (hepatic dysfunction and hematopoietic malignancies)
Up to 1 year
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)]
Up to 1 year
Hematologic response status
Time Frame: Up to 1 year
Hematologic response status to be provided
Up to 1 year
Change over time from baseline in platelet count
Time Frame: Baseline, 1 year
Change over time from baseline in platelet count to be provided
Baseline, 1 year
Change over time from baseline in hemoglobin
Time Frame: Baseline, 1 year
Change over time from baseline in hemoglobin to be provided
Baseline, 1 year
Change over time from baseline in neutrophil count
Time Frame: Baseline, 1 year
Change over time from baseline in neutrophil count to be provided
Baseline, 1 year
Change over time from baseline in reticulocyte count
Time Frame: Baseline, 1 year
Change over time from baseline in reticulocyte count to be provided
Baseline, 1 year
Change over time from baseline in transfusion dependence
Time Frame: Baseline, 1 year
Change over time from baseline in transfusion dependence to be provided
Baseline, 1 year
Change over time from baseline in transfusion volume
Time Frame: Baseline, 1 year
Change over time from baseline in transfusion volume to be provided
Baseline, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 17, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CETB115G1401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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