Thalassemic SyndromesALPHAPOOLNCT02855957
Evaluation of the Free α-hemoglobin Pool in the Red Blood Cells : Prognostic Marker and Severity Index in Thalassemic Syndromes
A study testing Free α-Hb pool analysis in people with Thalassemic Syndromes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Our project aims to assess and validate an innovative prognostic and diagnostic test in order to i) define a severity index of the β-thalassemia according to the free α-Hb pool for a better management of the patient; ii) differentiate the α-thalassemia and β-thalassemia and iii) follow the evolution of this pool in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thalassemic Syndromes
- What is being tested?
- Free α-Hb pool analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Jun 2016
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Written informed consent
- Affiliation to social security
- Known Hb Phenotypes
- Biological phenotype corresponding to a classical picture of thalassemia
- Healthy volunteers
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- Age ≥ 18 years
- Written informed consent
- Affiliation to social security
Who cannot join
- Transfusion for less than 3 months
- Chronic active viral disease: hepatitis B, C, HIV
- Ongoing infections or known inflammatory diseases
- Hyper or Hypothyroidism known or subject treated by Levothyrox
- Active pathology or tumor remission for less than 5 years
- Oral corticosteroid
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- Hemoglobinopathy other than thalassemia for patients
- Treatment by Hydroxyurea for more than 3 months
- Treatment by stimulating agent erythropoiesis for longer than 3 months
- Healthy volunteers
- Transfusion for less than 3 months
- Chronic active viral disease: hepatitis B, C, HIV
- Ongoing infections or known inflammatory diseases
- Hyper or Hypothyroidism known or subject treated by Levothyrox
- Active pathology or tumor remission for less than 5 years
- Oral corticosteroid
- Genetically related to person with hemoglobinopathy
Trial locations and contacts
1 site in 1 country.
About this study
Our project aims to assess and validate an innovative prognostic and diagnostic test in order to i) define a severity index of the β-thalassemia according to the free α-Hb pool for a better management of the patient; ii) differentiate the α-thalassemia and β-thalassemia and iii) follow the evolution of this pool in response to treatment of patients. In the future, this prognostic test based on the measurement of free α-Hb pool may be suitable for routine laboratory practice. To carry out this project, cohort of 85 thalassemic patients and a group of 50 healthy volunteers have been recruited.
- Conditions
- Thalassemic Syndromes
- Being tested
- Free α-Hb pool analysis
- Keywords
- Alpha-Hemoglobin Stabilizing Protein, alpha-Hb pool, thalassemias, diagnostic method, biomarker
- Medical subject headings
- Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free α-Hb pool analysisOther
| Study group | Role | What they receive |
|---|---|---|
| Blood sample | Other | A blood collection is carry out in the three populations of patients during the day of their enrolment. Receives: Other: Free α-Hb pool analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the pool of free α-Hb and genotype α and β -globin of the patient and if necessary with the genotype AHSP gene
Measured: Day 1
Secondary outcomes (6)
Correlation between the pool of free α-Hb and Hb value
Measured: Day 1
Correlation between the pool of free α-Hb and Mean Corpuscular Hb
Measured: Day 1
Correlation between the pool of free α-Hb and Mean Cell Volume
Measured: Day 1
Correlation between the pool of free α-Hb and percent of reticulocytes
Measured: Day 1
Correlation between the pool of free α-Hb and fetal Hb
Measured: Day 1
Correlation between the pool of free α-Hb and erythrocyte enzymes
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startJun 2013
- Primary completionJul 2015
- Study completionJun 2016
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 Thalassemic SyndromesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Paris 12 Val de Marne University
- Responsible party
- Sponsor
- Investigators
- Frédéric Galacteros, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855957
- Sponsor's protocol ID
- P120205
- Acronym
- ALPHAPOOL
- Status last verified
- Jul 2016
- First submitted
- 31 Jul 2016
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Vasseur C, Pissard S, Domingues-Hamdi E, Marden MC, Galacteros F, Baudin-Creuza V. Evaluation of the free alpha-hemoglobin pool in red blood cells: a new test providing a scale of beta-thalassemia severity. Am J Hematol. 2011 Feb;86(2):199-202. doi: 10.1002/ajh.21918.
PubMed 21264907
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Free α-hemoglobin Pool in the Red Blood Cells : Prognostic Marker and Severity Index in Thalassemic Syndromes
- ClinicalTrials.gov ID
- NCT02855957
- Acronym / sponsor ID
- ALPHAPOOL / P120205
- Conditions
- Thalassemic Syndromes
- Keywords
- Alpha-Hemoglobin Stabilizing Protein, alpha-Hb pool, thalassemias, diagnostic method, biomarker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Paris 12 Val de Marne University
- Study start
- Jun 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 4 Aug 2016 (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.
Our project aims to assess and validate an innovative prognostic and diagnostic test in order to i) define a severity index of the β-thalassemia according to the free α-Hb pool for a better management of the patient; ii) differentiate the α-thalassemia and β-thalassemia and iii) follow the evolution of this pool in response to treatment of patients. In the future, this prognostic test based on the measurement of free α-Hb pool may be suitable for routine laboratory practice. To carry out this project, cohort of 85 thalassemic patients and a group of 50 healthy volunteers have been recruited.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood sample | Other | Other: Free α-Hb pool analysisA blood collection is carry out in the three populations of patients during the day of their enrolment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years
- Written informed consent
- Affiliation to social security
- Known Hb Phenotypes
- Biological phenotype corresponding to a classical picture of thalassemia
Key exclusion criteria (17 listed)
- Transfusion for less than 3 months
- Chronic active viral disease: hepatitis B, C, HIV
- Ongoing infections or known inflammatory diseases
- Hyper or Hypothyroidism known or subject treated by Levothyrox
- Active pathology or tumor remission for less than 5 years
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 |
|---|---|---|
| Free α-Hb pool analysis | Other | Blood sample |
Primary outcome
Correlation between the pool of free α-Hb and genotype α and β -globin of the patient and if necessary with the genotype AHSP gene
Time frame: Day 1
6 secondary outcomes
Correlation between the pool of free α-Hb and Hb value
Time frame: Day 1
Correlation between the pool of free α-Hb and Mean Corpuscular Hb
Time frame: Day 1
Correlation between the pool of free α-Hb and Mean Cell Volume
Time frame: Day 1
Correlation between the pool of free α-Hb and percent of reticulocytes
Time frame: Day 1
Correlation between the pool of free α-Hb and fetal Hb
Time frame: Day 1
Correlation between the pool of free α-Hb and erythrocyte enzymes
Time frame: Day 1
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 Aug 2016.
- Background: PubMed 21264907Vasseur C, Pissard S, Domingues-Hamdi E, Marden MC, Galacteros F, Baudin-Creuza V. Evaluation of the free alpha-hemoglobin pool in red blood cells: a new test providing a scale of beta-thalassemia severity. Am J Hematol. 2011 Feb;86(2):199-202. doi: 10.1002/ajh.21918.
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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.
Frédéric Galacteros, MD PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free α-Hb pool analysis in people with Thalassemic Syndromes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 9 inclusion and 17 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 Aug 2016. 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 France. 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?
Correlation between the pool of free α-Hb and genotype α and β -globin of the patient and if necessary with the genotype AHSP gene (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02855957, 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 4 Aug 2016.