Revolade Tablets Specified Drug-use Survey

Recruiting now

Conditions studied: Aplastic Anemia

In brief

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).

Key facts

Study ID

NCT06287268

Run by

Novartis Pharmaceuticals

People needed

10

Starts

2024-07-17

Expected to finish

2028-10-31

Last updated by the study team

2026-02-19

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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"

You may not qualify if…

• 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 is running

• Novartis Investigative Site — Nagoya, Aichi-ken, Japan (enrolling)
• Novartis Investigative Site — Nagoya, Aichi-ken, Japan (enrolling)
• Novartis Investigative Site — Toyoake, Aichi-ken, Japan (enrolling)
• Novartis Investigative Site — Chiba, Chiba, Japan (enrolling)
• Novartis Investigative Site — Amagasaki, Hyōgo, Japan (enrolling)
• Novartis Investigative Site — Kobe, Hyōgo, Japan (enrolling)
• Novartis Investigative Site — Matsumoto, Nagano, Japan (enrolling)
• Novartis Investigative Site — Shimajiri-Gun, Okinawa, Japan (enrolling)
• Novartis Investigative Site — Izumi, Osaka, Japan (enrolling)
• Novartis Investigative Site — Osaka, Osaka, Japan (enrolling)
• Novartis Investigative Site — Sakai, Osaka, Japan (enrolling)
• Novartis Investigative Site — Saitama, Saitama, Japan (enrolling)
• Novartis Investigative Site — Ohtsu, Shiga, Japan (enrolling)
• Novartis Investigative Site — Chuo Ku, Tokyo, Japan (enrolling)
• Novartis Investigative Site — Ōta-ku, Tokyo, Japan (enrolling)
• Novartis Investigative Site — Setagaya-ku, Tokyo, Japan (enrolling)
• Novartis Investigative Site — Wakayama, Wakayama, Japan (enrolling)

Full record on ClinicalTrials.gov

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