Multicenter clinical study evaluating safety and efficacy of iron chelation therapy in patients with transfusion-induced iron overload

Multicenter clinical study evaluating safety and efficacy of iron chelation therapy in patients with transfusion-induced iron overload - Multicenter clinical study evaluating safety and efficacy of iron chelation therapy in patients with transfusion-induced iron overload

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000002515

Enrollment

100

Registered

2009-09-24

Start date

2008-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transfusion-induced iron overload

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who are transfusion dependent and are expected to survive for >1 year. Patients who have been transfused with >40 JPN units of pRBCs and/or whose serum ferritin levels are more than 1,000 ng/mL. With wrriten informed consent

Exclusion criteria

Exclusion criteria: Patients with severe renal or hepatic dysfunction. Patients who are pregnant or breastfeeding or expecting pregnancy. Patients with history of hypersensitivity to deferasirox. Patients who have been judged as inappropriate for any reasons by the concerning investigators.

Design outcomes

Primary

Measure	Time frame
Evaluating hematopoietic improvement	—

Secondary

Measure	Time frame
Evaluating improvement of other organ dysfunctions (hepatic dysfunction, cardiac dysfunction, glucose intolerance), and validity of the "Japanese guidelines for the treatment of transfusional iron overload"	—

Countries

Japan

Contacts

Public ContactTakahiro Suzuki

Jichi Medical University Division of Hematology, Department of Medicine

hematology@jichi.ac.jp0285-58-7353

Outcome results