Long Term Follow up in Sickle Cell Patients Treated by Hy... | NCT00480974

Studies
Long Term Follow up in Sickle Cell Patients Treated by Hydroxyurea

NCT00480974

Sponsor

HaEmek Medical Center, Israel

Status

Completed

Last Update Posted

Sep 4, 2009Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Sickle Cell Anemia
Sickle Cell Thalassemia

Interventions

Clinical follow up and laboratory analysis

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

May 31, 2007

First Submission Date that Met QC Criteria

May 31, 2007

First Posted Date

Jun 1, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2009

Last Update Posted Date

Sep 4, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Patients with Sickle cell anemia treated by Hydroxyurea	Other: Clinical follow up and laboratory analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clinical follow up and laboratory analysis	Other	Clinical follow up and laboratory analysis	1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients treated by Hydroxyurea in the Pediatric Hematology Unit.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pediatric Hematology Unit - HaEmek Medical Center		Afula		18101	Israel

Condition Browse Module

MeSH Terms

ID	Term
D000755	Anemia, Sickle Cell

Ancestor Terms

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided