null - FindTrial

A Multicenter Study to Monitor for the Potential Development of Renal Tumors in Subjects With Transfusional Iron Overload Who Were Previously Exposed to Deferitazole - N/A

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005086-70-IT

Enrollment

130

Registered

2021-01-19

Start date

2015-09-11

Completion date

Unknown

Last updated

2021-08-17

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

Conditions

n patients with B-thalassemia, regular transfusions are not only essential to maintain acceptable hemoglobin levels for treatment of the underlying anemia but also to suppress endogenous erythropoiesis and pathology due to chronic hemolysis. Unfortunately it inevitably leads to iron overload, such that all patients continuing to receive transfusions in excess of 20 blood transfusions are at progressively increased risk of developing signs or symptoms of iron overload. MedDRA version: 21.0 Level

Interventions

Product Name: FBS0701 capsule Product Code: FBS0701/SSP004184 Pharmaceutical Form: Capsule, hard CAS Number: 1173092-59-2 Current Sponsor code: FBS0701/SSP004184 Concentration unit: mg milligram(s) Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subject will not be considered eligible for the study without meeting all of the criteria below. 1. An understanding, ability, and willingness to fully comply with study procedures and restrictions. 2. Ability to voluntarily provide written, signed, and dated (personally or via a legally authorized representative) informed consent/and assent as applicable to participate in the study. 3. Subject was administered deferitazole for more than 3 days in a previous deferitazole study Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 104 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Not applicable – There are no exclusion criteria for this study

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to monitor for the potential development of renal tumors using ultrasound for up to 5 years in subjects who participated in previous deferitazole studies and who were administered study drug for more than 3 days. ;Secondary Objective: not applicable;Primary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Measure

Time frame

Main Objective: The primary objective of this study is to monitor for the potential development of renal tumors using ultrasound for up to 5 years in subjects who participated in previous deferitazole studies and who were administered study drug for more than 3 days. ;Secondary Objective: not applicable;Primary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable

—

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Italy

Contacts

Public ContactGlobal Clinical Development

Shire Development LLC and International Affiliates Paul Streck, MD

rabichan@shire.com781 482 9188

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026