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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01443312
Other study ID # 0047-10-EMC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2011
Est. completion date December 2014

Study information

Verified date October 2019
Source HaEmek Medical Center, Israel
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The definition of Thalassemia Intermedia is not generally accepted and the specific clinical and laboratory characteristics varies between patients. Some patients are blood transfusion dependent and others are occasionally transfused. Also the mutations in the beta globin gene are diverse. Another mutations including mutations in the alfa globin gene and in the xmn1 gene can affect the clinical course of this disease. The purpose of this study is to summarize the characteristics of patients with Thalassemia Intermedia treated at the Pediatric Hematology Unit at the HaEmek Medical Center in Israel


Description:

The characteristics that will be recorded from the medical files include: demographic data, included gender and ethnic origin, family history, age at diagnosis, number and frequency of blood transfusions including age of first transfusion and physical examination findings.

The laboratory data included iron metabolism parameters, mutation in the alfa and beta gene and the presence of the xmn1 polymorphism.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender All
Age group 1 Year to 40 Years
Eligibility Inclusion Criteria:

-All patients treated at the Pediatric Hematology Unit

Exclusion Criteria:

- Not enough medical records.

- Patients who refuse to give consent to perform genetic studies will be included in the study but only the retrospective clinical data will be recorded.

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
Laboratory analysis.
The blood transfusions given to the patients are in accord to physician decision and not related to the study

Locations

Country Name City State
Israel Pediatric Hematology Unit - Ha'Emek Medical Center Afula

Sponsors (1)

Lead Sponsor Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary The characteristics of patients with thalassemia intermedia Observational study that analyzed the characteristics of thalassemia intermedia patients One year
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