Skip to main content
OpenTrials
Completed

NCT Number: NCT02855957

Evaluation of the Free α-hemoglobin Pool in the Red Blood Cells : Prognostic Marker and Severity Index in Thalassemic Syndromes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Thalassemic Syndromes Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Thalassemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henri Mondor Hospital

Créteil, 94010, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Free α-Hb pool analysis

Other

Primary outcomes

  1. 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

Secondary outcomes

  1. Correlation between the pool of free α-Hb and Hb value

    Time frame: Day 1

  2. Correlation between the pool of free α-Hb and Mean Corpuscular Hb

    Time frame: Day 1

  3. Correlation between the pool of free α-Hb and Mean Cell Volume

    Time frame: Day 1

  4. Correlation between the pool of free α-Hb and percent of reticulocytes

    Time frame: Day 1

  5. Correlation between the pool of free α-Hb and fetal Hb

    Time frame: Day 1

  6. Correlation between the pool of free α-Hb and erythrocyte enzymes

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France
  • Paris 12 Val de Marne University

Registry information

Acronym: ALPHAPOOL

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Aug 4, 2016
Registry last updated
Aug 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.