To assess compliance, efficacy and satisfaction with two different formulation of deferasirox in patients with transfusion-dependent beta-thalassemia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015101218603N2

Enrollment

100

Registered

2015-12-21

Start date

2015-12-22

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Major Thalassaemia. Beta thalassaemia

Interventions

Intervention 1: Control group: 20-40 mg/kg/day dose regimen of EXJADE considering serum ferritin level. Frequency and route of administration is once per day orally. 20 mg/kg EXJADE (serum ferriti

Treatment - Drugs

Control group: 20-40 mg/kg/day dose regimen of EXJADE considering serum ferritin level. Frequency and route of administration is once per day orally. 20 mg/kg EXJADE (serum ferritin level: 1000-

Intervention group: 14-28 mg/kg/day dose regimen of JADENU considering serum ferritin level. Frequency and route of administration is once per day orally. 14 mg/kg JADENU (serum ferritin level: 1

Eligibility

Sex/Gender

All

Age

10 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: signing informed consent; male or female aged = 2 years at screening; patients with transfusion dependent thalassemia major; regular transfusion indicated by a blood requirement = 8 blood transfusions per year at screening. Exclusion criteria: patients with mean levels of ALT above 5 fold the upper limit of normal (ULN); patients with serum creatinine above ULN; significant proteinuria as indicated by a urinary protein/creatinine ratio> 0.6 (mg/mg); creatinine clearance = 60 ml/min; chronic hepatitis B infection; active hepatitis C infection; pregnancy or breastfeeding; non-transfusion dependent thalassemia (NTDT)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Patients compliance and satisfaction. Timepoint: three months after drug consumption. Method of measurement: designed questionnaire for patient compliance and satisfaction assessing.	—

Secondary

Measure	Time frame
Ferritin serum amount. Timepoint: at the beginning of the study and monthly for 3 months. Method of measurement: Using starfax device.;Safety. Timepoint: Base line, End of evey month for 3 months. Method of measurement: Follow up, clinical examination by expert hematologist.;Possible gastrointestinal side effects, including diarrhea, and dermatologic symptoms. Timepoint: Base line, End of every month for three months. Method of measurement: Follow up,clinical examination by expert hematologist.	—

Measure

Time frame

Ferritin serum amount. Timepoint: at the beginning of the study and monthly for 3 months. Method of measurement: Using starfax device.;Safety. Timepoint: Base line, End of evey month for 3 months. Method of measurement: Follow up, clinical examination by expert hematologist.;Possible gastrointestinal side effects, including diarrhea, and dermatologic symptoms. Timepoint: Base line, End of every month for three months. Method of measurement: Follow up,clinical examination by expert hematologist.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Sezaneh Haghpanah

Hematology Research Center, Nemazee Hospital, Shiraz, Iran

haghpanah@sums.ac.ir+98 71 3628 1563

Outcome results

None listed

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