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Comparative study of efficacy of Osveral and Desferal

Comparative study of efficacy of Osveral and Desferal in major thalassemia patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT201112118370N1
Enrollment
202
Registered
2012-02-04
Start date
2010-12-22
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 thalassemia. Beta thalassaemia

Interventions

Intervention 1: osveral 10-40 mg/kg/day. Intervention 2: desferal 20-40 mg/kg/day.
Treatment - Drugs
osveral 10-40 mg/kg/day
desferal 20-40 mg/kg/day

Sponsors

Kermanshah university of medical sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: Age, more than 2 years; Type of disease, major thalassemia or intermediate that have complete medical file; Serum ferritin, when reaches upper than 1000; Number of injections, if patient has injected more than 10 times or volume of blood injection is more than 100 cc/kg; Creatinin, should not be more than normal range; Patients should be negative of HIV, HBV, HCV; Liver enzymes should be less than 5 times of normal range; Cellular blood count (CBC) should be in normal range; Patients should not have any cardiac problem and should not use any cardiac drugs & patients should have EF>55% and LVEDE<40cc/m² in echocardiography; Patients should not have visual & auditory problems; Patients should not have any proteinuria in urine analysis (Pr/Cr should not be more than 0.6mg in random urine sampling; Preferentiality, pregnant or lactiferous women should not take part in this study. Exclusion criteria: Increase of creatinin, if creatinin gets upper normal range (for age) in study or gets more than 33% of basic creatinin rate (before beginning of study); Occurrence of cardiac diseases according to annual checking (control); Occurrence of visual & auditory problems according to annual checking; If serologic tests of HIV or hepatitis gets positive according to annual checking; Increase of liver enzymes more than 5 times of the normal range; Occurrence of pancytopenia, including platelet count less than 150000/mm³ or exact count of PMN less than1500/ mm; In conditions of nausea, sever vomiting & irresponseness to antiemetics & hydration by physicians; In occurrences of sever dermal rashes & lack of recovery or progressive increase of them.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Serum ferritin. Timepoint: 1 month. Method of measurement: Blood test.

Secondary

MeasureTime frame
Dermatologic, gastrointestinal, liver and renal complications. Timepoint: Monthly. Method of measurement: Blood test and examination by physician.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Reza Akramipour

Kermanshah university of medical sciences

akramipour20@kums.ac.ir+98 83142763017

Outcome results

None listed

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