Investigating the efficacy and safety of twice daily Nanojade in transfusion-dependent thalassemia patients

Evaluation of the efficacy and safety of Nanojade twice daily versus Nanojade once daily in transfusion-dependent thalassemia patients

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20100110003032N3

Enrollment

Registered

2023-02-28

Start date

2023-03-06

Completion date

Unknown

Last updated

2023-03-13

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

Conditions

Major beta-thalassemia. Beta thalassemia

Interventions

Intervention 1: Intervention group: 14 to 20 mg of Nanojade, product of Nanohayat company, twice daily for 12 months. Intervention 2: Control group: 14 to 20 mg of Nanojade, product of Nanohayat compa

Eligibility

Sex/Gender

All

Age

2 Years to No maximum

Inclusion criteria

Inclusion criteria: Age 2 years and older Blood transfusion-dependent major beta-thalassemia Under treatment with single iron chelator for at least 6 months and ferritin above 2500 ng/dL or patient with gastrointestinal side effects and ferritin above 2500 nd/dL

Exclusion criteria

Exclusion criteria: Unwillingness to participate in the study

Design outcomes

Primary

Measure	Time frame
Liver Iron Concentration (LIC) mg Fe/g. Timepoint: Before starting the intervention and 6-12 months after the intervention. Method of measurement: Liver biopsy.	—

Secondary

Measure	Time frame
Serum Urea concentration. Timepoint: Monthly after start of intervention until 12 month. Method of measurement: Serum biochemistry.;Drug side effects. Timepoint: At the start of intervention until end of intervention. Method of measurement: Patient report.;Serum Ferritin. Timepoint: At the start of intervention until end of intervention. Method of measurement: Serum biochemistry assay.;Serum Creatinine concentration (mg/dL). Timepoint: Monthly after start of intervention until 12 month. Method of measurement: Serum biochemistry assay.;Serum Calcium concentration (mg/dL). Timepoint: Monthly after start of intervention until 12 month. Method of measurement: Serum biochemistry assay.;Serum Phosphor concentration (mg/dL). Timepoint: Monthly after start of intervention until 12 month. Method of measurement: Serum biochemistry assay.;Serum Alanine Aminotransferase concentration (mg/dL). Timepoint: Monthly after start of intervention until 12 month. Method of measurement: Serum biochemistry assay.;Serum Aspartate Aminotransferase (mg/dL). Timepoint: Monthly after start of intervention until 12 month. Method of measurement: Serum biochemistry assay.;Serum Alkaline Phosphates (mg/dL). Timepoint: Monthly after start of intervention until 12 month. Method of measurement: Serum biochemistry assay.;Serum Bilirubin concentration (mg/dL). Timepoint: Monthly after start of intervention until 12 month. Method of measurement: Serum biochemistry assay.	—

Measure

Time frame

Serum Urea concentration. Timepoint: Monthly after start of intervention until 12 month. Method of measurement: Serum biochemistry.;Drug side effects. Timepoint: At the start of intervention until end of intervention. Method of measurement: Patient report.;Serum Ferritin. Timepoint: At the start of intervention until end of intervention. Method of measurement: Serum biochemistry assay.;Serum Creatinine concentration (mg/dL). Timepoint: Monthly after start of intervention until 12 month. Method of measurement: Serum biochemistry assay.;Serum Calcium concentration (mg/dL). Timepoint: Monthly after start of intervention until 12 month. Method of measurement: Serum biochemistry assay.;Serum Phosphor concentration (mg/dL). Timepoint: Monthly after start of intervention until 12 month. Method of measurement: Serum biochemistry assay.;Serum Alanine Aminotransferase concentration (mg/dL). Timepoint: Monthly after start of intervention until 12 month. Method of measurement: Serum biochemistry assay.;Serum Aspartate Aminotransferase (mg/dL). Timepoint: Monthly after start of intervention until 12 month. Method of measurement: Serum biochemistry assay.;Serum Alkaline Phosphates (mg/dL). Timepoint: Monthly after start of intervention until 12 month. Method of measurement: Serum biochemistry assay.;Serum Bilirubin concentration (mg/dL). Timepoint: Monthly after start of intervention until 12 month. Method of measurement: Serum biochemistry assay.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHossein Karami

Mazandaran University of Medical Sciences

hokarami@mazums.ac.ir00981512144295

Outcome results

None listed

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