Alpha ThalassemiaNCT00159029
Genetics of Alpha Thalassemia in Israeli Ethnic Groups
An observational study of Alpha Thalassemia, run by Deborah Rund at 1 site in Israel.
Trial summary
Alpha thalassemia causes mild anemia and is found in many ethnic groups. Usually it is found in regions where malaria is endemic. We have found that alpha thalassemia is common in Ashkenazim, whose countries of origin are in temperate climates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alpha Thalassemia
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2004to 1 Jul 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who come to Hadassah Hospital for anemia with microcytosis who are found to have alpha thalassemia.
Who may be able to join
- diagnosis of deletional alpha thalassemia
Who cannot join
- under age 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Haplotype Analysis of Alpha Globin Genes in Israeli Ethnic Groups
Alpha thalassemia causes mild anemia and is found in many ethnic groups. Usually it is found in regions where malaria is endemic. We have found that alpha thalassemia is common in Ashkenazim, whose countries of origin are in temperate climates.
We are analyzing the alpha globin genes of individuals of many ethnic groups and will compare to try to define the origin of thalassemia in these individuals of European extraction.
Read the detailed description
Alpha thalassemia causes mild anemia and is found in many ethnic groups. Usually it is found in regions where malaria is endemic. We have found that alpha thalassemia is common in Ashkenazim, whose countries of origin are in temperate climates.
We are analyzing the alpha globin polymorphisms to determine the haplotypes of individuals of many ethnic groups and will compare to try to define the origin of thalassemia in these individuals of European extraction.
- Conditions
- Alpha Thalassemia
- Medical subject headings
- alpha-Thalassemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study start1 Apr 2004
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alpha ThalassemiaStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deborah Rund
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Deborah Rund, Hadassah Medical Organization
- Investigators
- Deborah Rund, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159029
- Sponsor's protocol ID
- 152910-HMO-CTIL
- Status last verified
- Aug 2017
- First submitted
- 9 Sep 2005
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Rund D, Filon D, Jackson N, Asher N, Oron-Karni V, Sacha T, Czekalska S, Oppenheim A. An unexpectedly high frequency of heterozygosity for alpha-thalassemia in Ashkenazi Jews. Blood Cells Mol Dis. 2004 Jul-Aug;33(1):1-3. doi: 10.1016/j.bcmd.2004.04.009.
PubMed 15223003
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haplotype Analysis of Alpha Globin Genes in Israeli Ethnic Groups
- ClinicalTrials.gov ID
- NCT00159029
- Acronym / sponsor ID
- 152910-HMO-CTIL
- Conditions
- Alpha Thalassemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Deborah RundUniversity, hospital or other
- Study start
- 1 Apr 2004 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 12 Sep 2005 (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.
Alpha thalassemia causes mild anemia and is found in many ethnic groups. Usually it is found in regions where malaria is endemic. We have found that alpha thalassemia is common in Ashkenazim, whose countries of origin are in temperate climates.
We are analyzing the alpha globin genes of individuals of many ethnic groups and will compare to try to define the origin of thalassemia in these individuals of European extraction.
Detailed description
Alpha thalassemia causes mild anemia and is found in many ethnic groups. Usually it is found in regions where malaria is endemic. We have found that alpha thalassemia is common in Ashkenazim, whose countries of origin are in temperate climates.
We are analyzing the alpha globin polymorphisms to determine the haplotypes of individuals of many ethnic groups and will compare to try to define the origin of thalassemia in these individuals of European extraction.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who come to Hadassah Hospital for anemia with microcytosis who are found to have alpha thalassemia.
Key inclusion criteria (1 listed)
- diagnosis of deletional alpha thalassemia
Key exclusion criteria (1 listed)
- under age 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 10 Aug 2017.
- Background: PubMed 15223003Rund D, Filon D, Jackson N, Asher N, Oron-Karni V, Sacha T, Czekalska S, Oppenheim A. An unexpectedly high frequency of heterozygosity for alpha-thalassemia in Ashkenazi Jews. Blood Cells Mol Dis. 2004 Jul-Aug;33(1):1-3. doi: 10.1016/j.bcmd.2004.04.009.
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A Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Participants With α- or β-Non-Transfusion-Dependent Thalassemia
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RecruitingPhase 2
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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.
Deborah Rund, MD principal investigator
Hadassah Medical Organization
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 Alpha Thalassemia, run by Deborah Rund 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 10 Aug 2017. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00159029, which also lists 1 linked publication.
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 10 Aug 2017.