Thalassemia AlphaNCT00971984
Demographic, Clinical and Laboratory Characteristics of Children With Alpha Thalassemia in Northern Israel
An observational study of Thalassemia Alpha and Hemolytic Anemia, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
The study intends to summarize the clinical and laboratory characteristics of children with hemolytic anemia diagnosed as having alpha thalassemia mutations. Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Thalassemia Alpha, Hemolytic Anemia
- What is being tested?
- Medical records summary
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2009to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: A group of 50 children that underwent workup due to hemolytic anemia and were further diagnosis as suffering from clinical alpha thalassemia.
Who may be able to join
- All the patients that were studied at the pediatric hematology unit ant the Ha'Emek Medical Center
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Israel1 site
Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center
Afula, 18101
About this study
The study intends to summarize the clinical and laboratory characteristics of children with hemolytic anemia diagnosed as having alpha thalassemia mutations.
Read the detailed description
Fifty children and adolescents diagnosed as having alpha thalassemia will be studied, the clinical characteristics and hematology analysis will be summarized.
- Conditions
- Thalassemia Alpha, Hemolytic Anemia
- Being tested
- Medical records summary
- Medical subject headings
- alpha-Thalassemia, Anemia, Hemolytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical records summaryOther
Summary of Medical files and laboratory results.
| Study group | Role | What they receive |
|---|---|---|
| Alpha thalassemia patients | Patients diagnosed with alpha thalassemia mutations and anemia Receives: Other: Medical records summary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the Demographic, Clinical and Laboratory Characteristics of Children With Alpha Thalassemia
Analysis of the Demographic, Clinical and Laboratory Characteristics of Children With Alpha Thalassemia
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thalassemia AlphaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Koren Ariel, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971984
- Sponsor's protocol ID
- 0074-09-EMC
- Status last verified
- Aug 2015
- First submitted
- 3 Sep 2009
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demographic, Clinical and Laboratory Characteristics of Children With Alpha Thalassemia in Northern Israel
- ClinicalTrials.gov ID
- NCT00971984
- Acronym / sponsor ID
- 0074-09-EMC
- Conditions
- Thalassemia Alpha, Hemolytic Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 4 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study intends to summarize the clinical and laboratory characteristics of children with hemolytic anemia diagnosed as having alpha thalassemia mutations.
Detailed description
Fifty children and adolescents diagnosed as having alpha thalassemia will be studied, the clinical characteristics and hematology analysis will be summarized.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alpha thalassemia patients | – | Other: Medical records summaryPatients diagnosed with alpha thalassemia mutations and anemia |
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- A group of 50 children that underwent workup due to hemolytic anemia and were further diagnosis as suffering from clinical alpha thalassemia.
Key inclusion criteria (1 listed)
- All the patients that were studied at the pediatric hematology unit ant the Ha'Emek Medical Center
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical records summarySummary of Medical files and laboratory results. | Other | Alpha thalassemia patients |
Primary outcome
Analysis of the Demographic, Clinical and Laboratory Characteristics of Children With Alpha Thalassemia
Time frame: One year
Analysis of the Demographic, Clinical and Laboratory Characteristics of Children With Alpha Thalassemia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thalassemia Alpha and Hemolytic Anemia, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the Demographic, Clinical and Laboratory Characteristics of Children With Alpha Thalassemia (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2015.