Sickle Cell AnemiaNCT00480974
Long Term Follow up in Sickle Cell Patients Treated by Hydroxyurea
An observational study of Sickle Cell Anemia and Sickle Cell Thalassemia, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Hydroxyurea was found to be a good treatment in adult patients with sickle cell anemia with significant decrease in the frequency of vaso-occlusive crises and other crises related to SCA. Several studies were published with relative short term follow up in pediatric and young adult age. Read more about this study
- Who is it for?
- Ages 5 to 40 years
- Conditions the study is for
- Sickle Cell Anemia, Sickle Cell Thalassemia
- What is being tested?
- Clinical follow up and laboratory analysis
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- May 2007to Dec 2008
- 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 5 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with Sickle Cell Anemia treated at the Pediatric Hematology Unit and receiving Hydroxyurea
Who may be able to join
- All patients treated by Hydroxyurea in the Pediatric Hematology Unit.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Follow up in Sickle Cell Patients Treated by Hydroxyurea.Observational Retrospective Study.
Hydroxyurea was found to be a good treatment in adult patients with sickle cell anemia with significant decrease in the frequency of vaso-occlusive crises and other crises related to SCA. Several studies were published with relative short term follow up in pediatric and young adult age. The purpose of this study is to assess the long term follow up in a group of patients that initiated Hydroxyurea treatment in childhood.
Read the detailed description
Hydroxyurea was found to be a good treatment in adult patients with sickle cell anemia with significant decrease in the frequency of vaso-occlusive crises and other crises related to SCA. Several studies were published with relative short term follow up in pediatric and young adult age. The purpose of this study is to assess the long term follow up in a group of patients that initiated Hydroxyurea treatment in childhood.
A long term follow up will be recorded in a cohort of twenty SCA patients treated by Hydroxyurea for a period between 5 to 12 years. The frequency of vaso-occlusive crises, acute chest syndrome, blood transfusions, and hospitalization will be recorded retrospectively. Also the mean hgb level and hgb F percentage will be summarized.
- Conditions
- Sickle Cell Anemia, Sickle Cell Thalassemia
- Being tested
- Clinical follow up and laboratory analysis
- Keywords
- Sickle cell anemia, Sickle cell thalassemia, Hydroxyurea
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical follow up and laboratory analysisOther
Clinical follow up and laboratory analysis
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with Sickle cell anemia treated by Hydroxyurea Receives: Other: Clinical follow up and laboratory analysis |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2007 (estimated)
- Study startMay 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell AnemiaStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Investigators
- Ariel Koren, MD, Study director, Pediatric Hematology Unit, Ha'Emek Medical CenterCarina Levin, MD, Study chair, Pediatric Hematology Unit - Ha'Emek Medical CenterMiri Golan, Student, Principal investigator, Pediatric Hematology Unit - HaEmek Medical CenterLuci Zalman, PhD, Study chair, Hematology Laboratory - HaEmek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480974
- Sponsor's protocol ID
- 5321006.EMC
- Status last verified
- Sep 2009
- First submitted
- 31 May 2007
- Last updated
- 4 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow up in Sickle Cell Patients Treated by Hydroxyurea.Observational Retrospective Study.
- ClinicalTrials.gov ID
- NCT00480974
- Acronym / sponsor ID
- 5321006.EMC
- Conditions
- Sickle Cell Anemia, Sickle Cell Thalassemia
- Keywords
- Sickle cell anemia, Sickle cell thalassemia, Hydroxyurea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 1 Jun 2007 (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.
Hydroxyurea was found to be a good treatment in adult patients with sickle cell anemia with significant decrease in the frequency of vaso-occlusive crises and other crises related to SCA. Several studies were published with relative short term follow up in pediatric and young adult age. The purpose of this study is to assess the long term follow up in a group of patients that initiated Hydroxyurea treatment in childhood.
Detailed description
Hydroxyurea was found to be a good treatment in adult patients with sickle cell anemia with significant decrease in the frequency of vaso-occlusive crises and other crises related to SCA. Several studies were published with relative short term follow up in pediatric and young adult age. The purpose of this study is to assess the long term follow up in a group of patients that initiated Hydroxyurea treatment in childhood.
A long term follow up will be recorded in a cohort of twenty SCA patients treated by Hydroxyurea for a period between 5 to 12 years. The frequency of vaso-occlusive crises, acute chest syndrome, blood transfusions, and hospitalization will be recorded retrospectively. Also the mean hgb level and hgb F percentage will be summarized.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Clinical follow up and laboratory analysisPatients with Sickle cell anemia treated by Hydroxyurea |
Who may qualify
- Ages
- 5 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with Sickle Cell Anemia treated at the Pediatric Hematology Unit and receiving Hydroxyurea
Key inclusion criteria (1 listed)
- All patients treated by Hydroxyurea in the Pediatric Hematology Unit.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Clinical follow up and laboratory analysisClinical follow up and laboratory analysis | Other | 1 |
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 4 Sep 2009.
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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.
Ariel Koren, MD study director
Pediatric Hematology Unit, Ha'Emek Medical Center
Carina Levin, MD study chair
Pediatric Hematology Unit - Ha'Emek Medical Center
Miri Golan, Student principal investigator
Pediatric Hematology Unit - HaEmek Medical Center
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 Sickle Cell Anemia and Sickle Cell Thalassemia, 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 0 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 4 Sep 2009. 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?
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 4 Sep 2009.