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Study of Hydroxyurea to Treat Sickle Cell Disease

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.
 
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

Study Description
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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.

Condition or disease
Sickle Cell Disease

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 Design
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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Clinical Effectiveness, Quality of Life, and Compliance in Patients With Sickle Cell Disease Receiving Hydroxyurea
Study Start Date : May 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Hydroxyurea

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Effectiveness and acceptance of hydroxyurea therapy in patients [ Time Frame: Up to 12 weeks ]

Secondary Outcome Measures :
  1. Demographic characteristics of patients using Demographic Data Collection Form [ Time Frame: Up to 12 weeks ]
  2. Clinical characteristics of patients using Case Report Form [ Time Frame: Up to 12 weeks ]
  3. Health status of pediatric patients using Child Health Questionnaire-Parent Form [ Time Frame: Up to 12 weeks ]
  4. Quality of life of young adult patients using Life Quality Survey Short Form-36 [ Time Frame: Up to 12 weeks ]
  5. Effectiveness of hydroxyurea therapy in patients using Case Report Form [ Time Frame: Up to 12 weeks ]
  6. Acceptance of hydroxyurea therapy in patients using Hydroxyurea Satisfaction Survey [ Time Frame: Up to 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   7 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
Contacts and Locations
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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): NCT02868138


Locations
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Turkey
Selma Unal
Mersin, Turkey, 33169
Sponsors and Collaborators
Mersin University
Investigators
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Study Chair: BAHAR TUNCTAN, Ph.D. MERSIN UNIVERSITY FACULTY OF PHARMACY DEPARTMENT OF PHARMACOLOGY
More Information
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Responsible Party: Bahar TUNCTAN, Prof. Dr., Mersin University
ClinicalTrials.gov Identifier: NCT02868138    
Other Study ID Numbers: MEUKAEK-2016/27 - 16-AKD-19
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Bahar TUNCTAN, Mersin University:
Sickle cell disease
Hydroxyurea
Compliance
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn