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Long Term Follow up in Sickle Cell Patients Treated by Hydroxyurea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00480974
First Posted: June 1, 2007
Last Update Posted: September 4, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
HaEmek Medical Center, Israel
  Purpose
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.

Condition Intervention
Sickle Cell Anemia Sickle Cell Thalassemia Other: Clinical follow up and laboratory analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Long Term Follow up in Sickle Cell Patients Treated by Hydroxyurea.Observational Retrospective Study.

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Estimated Enrollment: 20
Study Start Date: May 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients with Sickle cell anemia treated by Hydroxyurea
Other: Clinical follow up and laboratory analysis
Clinical follow up and laboratory analysis

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Sickle Cell Anemia treated at the Pediatric Hematology Unit and receiving Hydroxyurea
Criteria

Inclusion Criteria:

  • All patients treated by Hydroxyurea in the Pediatric Hematology Unit.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00480974


Locations
Israel
Pediatric Hematology Unit - HaEmek Medical Center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Study Director: Ariel Koren, MD Pediatric Hematology Unit, Ha'Emek Medical Center
Study Chair: Carina Levin, MD Pediatric Hematology Unit - Ha'Emek Medical Center
Principal Investigator: Miri Golan, Student Pediatric Hematology Unit - HaEmek Medical Center
Study Chair: Luci Zalman, PhD Hematology Laboratory - HaEmek Medical Center
  More Information

Responsible Party: Dr Koren Ariel, Pediatric Hematology Unit - HaEmek Medical Center - Afula - Israel
ClinicalTrials.gov Identifier: NCT00480974     History of Changes
Other Study ID Numbers: 5321006.EMC
First Submitted: May 31, 2007
First Posted: June 1, 2007
Last Update Posted: September 4, 2009
Last Verified: September 2009

Keywords provided by HaEmek Medical Center, Israel:
Sickle cell anemia
Sickle cell thalassemia
Hydroxyurea

Additional relevant MeSH terms:
Thalassemia
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Hydroxyurea
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors