NCT00480974

Brief 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. The purpose of this study is to assess the long term follow up in a group of patients that initiated Hydroxyurea treatment in childhood.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 31, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 1, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

September 4, 2009

Status Verified

September 1, 2009

Enrollment Period

1.6 years

First QC Date

May 31, 2007

Last Update Submit

September 3, 2009

Conditions

Sickle Cell AnemiaSickle Cell Thalassemia

Keywords

Sickle cell anemiaSickle cell thalassemiaHydroxyurea

Study Arms (1)

1

Patients with Sickle cell anemia treated by Hydroxyurea

Other: Clinical follow up and laboratory analysis

Interventions

Clinical follow up and laboratory analysisOTHER

Clinical follow up and laboratory analysis

1

Eligibility Criteria

Age5 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with Sickle Cell Anemia treated at the Pediatric Hematology Unit and receiving Hydroxyurea

You may qualify if:

  • All patients treated by Hydroxyurea in the Pediatric Hematology Unit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Hematology Unit - HaEmek Medical Center

Afula, 18101, Israel

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Ariel Koren, MD

    Pediatric Hematology Unit, Ha'Emek Medical Center

    STUDY DIRECTOR

  • Carina Levin, MD

    Pediatric Hematology Unit - Ha'Emek Medical Center

    STUDY CHAIR

  • Miri Golan, Student

    Pediatric Hematology Unit - HaEmek Medical Center

    PRINCIPAL INVESTIGATOR

  • Luci Zalman, PhD

    Hematology Laboratory - HaEmek Medical Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 31, 2007

First Posted

June 1, 2007

Study Start

May 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

September 4, 2009

Record last verified: 2009-09

Locations

IL(1)