Thalassemic Syndromes Clinical Trial
— ALPHAPOOLOfficial title:
Evaluation of the Free α-hemoglobin Pool in the Red Blood Cells : Prognostic Marker and Severity Index in Thalassemic Syndromes
| Verified date | July 2016 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: Ministry of Health |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 135 |
| Est. completion date | June 2016 |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria Patient - Age = 18 years - Written informed consent - Affiliation to social security - Known Hb Phenotypes - Biological phenotype corresponding to a classical picture of thalassemia Healthy volunteers - Age = 18 years - Written informed consent - Affiliation to social security Exclusion Criteria Patient - 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 - 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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| France | Henri Mondor Hospital | Creteil |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris | Institut National de la Santé Et de la Recherche Médicale, France, Paris 12 Val de Marne University |
France,
Vasseur C, Pissard S, Domingues-Hamdi E, Marden MC, Galactéros F, Baudin-Creuza V. Evaluation of the free a-hemoglobin pool in red blood cells: a new test providing a scale of ß-thalassemia severity. Am J Hematol. 2011 Feb;86(2):199-202. doi: 10.1002/ajh.21918. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Correlation between the pool of free a-Hb and genotype a and ß -globin of the patient and if necessary with the genotype AHSP gene | Day 1 | No | |
| Secondary | Correlation between the pool of free a-Hb and Hb value | Day 1 | No | |
| Secondary | Correlation between the pool of free a-Hb and Mean Corpuscular Hb | Day 1 | No | |
| Secondary | Correlation between the pool of free a-Hb and Mean Cell Volume | Day 1 | No | |
| Secondary | Correlation between the pool of free a-Hb and percent of reticulocytes | Day 1 | No | |
| Secondary | Correlation between the pool of free a-Hb and fetal Hb | Day 1 | No | |
| Secondary | Correlation between the pool of free a-Hb and erythrocyte enzymes | Day 1 | No |