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Study of Hydroxyurea to Treat Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT02868138
Recruitment Status : Completed
First Posted : August 16, 2016
Last Update Posted : August 16, 2016
Sponsor:
Information provided by (Responsible Party):
Bahar TUNCTAN, Mersin University

Tracking Information
First Submitted Date August 8, 2016
First Posted Date August 16, 2016
Last Update Posted Date August 16, 2016
Study Start Date May 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 13, 2016)
Effectiveness and acceptance of hydroxyurea therapy in patients [ Time Frame: Up to 12 weeks ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 13, 2016)
  • Demographic characteristics of patients using Demographic Data Collection Form [ Time Frame: Up to 12 weeks ]
  • Clinical characteristics of patients using Case Report Form [ Time Frame: Up to 12 weeks ]
  • Health status of pediatric patients using Child Health Questionnaire-Parent Form [ Time Frame: Up to 12 weeks ]
  • Quality of life of young adult patients using Life Quality Survey Short Form-36 [ Time Frame: Up to 12 weeks ]
  • Effectiveness of hydroxyurea therapy in patients using Case Report Form [ Time Frame: Up to 12 weeks ]
  • Acceptance of hydroxyurea therapy in patients using Hydroxyurea Satisfaction Survey [ Time Frame: Up to 12 weeks ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Hydroxyurea to Treat Sickle Cell Disease
Official Title Evaluation of Clinical Effectiveness, Quality of Life, and Compliance in Patients With Sickle Cell Disease Receiving Hydroxyurea
Brief Summary The aim of this single-center observational study was to evaluate quality of life, clinical effectiveness, and satisfaction in pediatric and young adult patients with sickle cell disease receiving hydroxyurea.
Detailed Description

In this study, 34 pediatric (HbSS: n= 5; HbSβ0: n= 29) and 16 (HbSS: n=5; HbSβ0: n= 11) young adult adult patients with sickle cell disease receiving hydroxyurea for at least a year were participated. Upon receipt of Informed Consent Form, Case Report Form, Demographic Data Collection Form, Child Health Questionnaire-Parent Form, Life Quality Survey Short Form-36, and Hydroxyurea Therapy Satisfaction Survey were used to obtain data for effectiveness of hydroxyurea therapy and parameters that may affect compliance to treatment and life quality of the participants.

Regarding the normal ranges, ferritin, hemoglobin A, A2, F, and S, platelet, mean corpuscular volume, erythrocyte distribution width, basophil percentage, monocyte, monocyte percentage, total bilirubin, direct bilirubin, and C-reactive protein values were higher while hemoglobin, hematocrit, and erythrocyte values were lower in these patients. Our findings regarding quality of life and satisfaction with hydroxyurea therapy indicated that the patients with sickle cell disease had lower scores.

Demographic, clinical, and therapeutic variables as well as comorbid diseases and concomitant drug use when considered together, these findings suggest that the health quality and compliance of the pediatric and young adult patients to therapy might be low due to not sufficiently effective hydroxyurea therapy in addition to comorbidities, concomitant drug use, and side effects.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pediatric (7-17 years) and young adult (18-22 years) patients with sickle cell disease who received hydroxyurea
Condition Sickle Cell Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 13, 2016)
50
Original Actual Enrollment Same as current
Actual Study Completion Date July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Patients willing to participate in the study
  2. Pediatric and young adult patients
  3. Patients diagnosed with HbSS or HbSβ0 sickle cell disease
  4. Patients receiving hydroxyurea for at least a year.

Exclusion Criteria:

  1. Patients not meeting the inclusion criteria
  2. Patients not willing to participate in the study
  3. Patients diagnosed with other types of anemia except HbSS or HbSβ0 sickle cell disease
  4. Patients not receiving hydroxyurea for at least a year
  5. Patients having other conditions such as physical and/or mental difficulties which may affect their quality of life
  6. Patients having any contrindication against hydroxyurea
Sex/Gender
Sexes Eligible for Study: All
Ages 7 Years to 22 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT02868138
Other Study ID Numbers MEUKAEK-2016/27 - 16-AKD-19
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Responsible Party Bahar TUNCTAN, Mersin University
Study Sponsor Mersin University
Collaborators Not Provided
Investigators
Study Chair: BAHAR TUNCTAN, Ph.D. MERSIN UNIVERSITY FACULTY OF PHARMACY DEPARTMENT OF PHARMACOLOGY
PRS Account Mersin University
Verification Date August 2016