A 4-year Extension Study to Core 1-year Study of Iron Chelation Therapy With Deferasirox in ß-thalassemia Major Pediatric Patients With Transfusional Iron Overload.

Phase 1

• Conditions: MedDRA version: 19.0Level: LLTClassification code 10054661Term: Thalassemia majorSystem Organ Class: 100000004850; MedDRA version: 19.0Level: LLTClassification code 10054660Term: Thalassemia betaSystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2015-003535-35-Outside-EU/EEA
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-08
• Last Update Posted: 4 July 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

•Completion of the planned 12-month core trial, (NCT00390858).
•Female patients who have reached menarche and who were sexually active were to use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation.
•Written informed consent obtained from the patient, and/or from the parent or legal guardian in accordance with the national legislation.

Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Pregnant or breast feeding patients
•Patients with a history of non-compliance to medical regimens and patients who are considered by the investigator as potentially unreliable.

Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified