Effect of Osveral on iron overload in beta thalassemia major patients.

A comparative study on efficacy of Deferasirox (Exjade) versus Osveral in treatment of iron overload in patients with beta thalassemia major

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015102524679N2

Enrollment

Registered

2016-06-16

Start date

2015-03-21

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

beta thalassemia. beta thalassemia

Interventions

Intervention 1: Intervention group 1: Osveral (Iron chelating agent, Osveh Company, Iran) was given as follows. The starting dose was 20 mg/kg/d for Osveral and the ferritin level measured each three

Treatment - Drugs

Intervention group 1: Osveral (Iron chelating agent, Osveh Company, Iran) was given as follows. The starting dose was 20 mg/kg/d for Osveral and the ferritin level measured each three months up to tw

Intervention group 2: ?Deferasirox (Exjade, Iron chelator agent, Novartis company, Switzerland) was given to this group. The starting dose was 20 mg/kg/d for Deferasirox and the ferritin level measur

Eligibility

Sex/Gender

All

Age

No minimum to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: equal or more than 2 years old; normal creatinine level; no proteinuria; negative for hepatitis B and C or HIV; hepatic transaminase less than 5 time above normal values; nornal CBC; No cardiac disorder; the ferritin level more than 1000; transfusion more than 10 times. Exclusion criteria: severe heart failure; patients who can not tolerate MRI; keeping liver transaminase more than five folds; repeated cytopenia; nausea and vomiting; skin rashes; and elevated serum creatinine.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Serum ferritin. Timepoint: before the intervention and every 3 monthes. Method of measurement: ELISA method, ng/ml.;The liver iron overloads. Timepoint: at the biginning of the intervention and after 12 monthes. Method of measurement: MRI T2.;The heart iron overloads. Timepoint: at the biginning of the intervention and after 12 monthes. Method of measurement: MRI T2.	—

Secondary

Measure	Time frame
AST. Timepoint: at the biginning of the study and every 3 monthes. Method of measurement: Specterophotometery method, mIU/l.;ALT. Timepoint: at the biginning of the study and every 3 monthes. Method of measurement: Specterophotometery method, mIU/l.;Serum Creatinin. Timepoint: at the biginning of the study and every 3 monthes. Method of measurement: Jaffeh method, mg/dl.;Urine Creatinin. Timepoint: at the biginning of the study and every 3 monthes. Method of measurement: mg/dl.;Urine Pr. Timepoint: at the biginning of the study and every 3 monthes. Method of measurement: mg/dl.	—

Measure

Time frame

AST. Timepoint: at the biginning of the study and every 3 monthes. Method of measurement: Specterophotometery method, mIU/l.;ALT. Timepoint: at the biginning of the study and every 3 monthes. Method of measurement: Specterophotometery method, mIU/l.;Serum Creatinin. Timepoint: at the biginning of the study and every 3 monthes. Method of measurement: Jaffeh method, mg/dl.;Urine Creatinin. Timepoint: at the biginning of the study and every 3 monthes. Method of measurement: mg/dl.;Urine Pr. Timepoint: at the biginning of the study and every 3 monthes. Method of measurement: mg/dl.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNeda Ashayeri

Mofid Hospital

neda_ashayeri@yahoo.com+886 86772

Outcome results

None listed

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