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Trial record 39 of 696 for:    sickle cell disease

Assessment of Algorithm-Based Hydroxyurea Dosing on Fetal Hemoglobin Response, Acute Complications, and Organ Function in People With Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT02225132
Recruitment Status : Completed
First Posted : August 26, 2014
Results First Posted : August 6, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sickle Cell Disease
Intervention Drug: Hydroxyurea
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Hydroxyurea
Hide Arm/Group Description Hydroxyurea is given to the patients as per a dosing algorithm.
Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Hydroxyurea
Hide Arm/Group Description Hydroxyurea is given to the patients as per a dosing algorithm.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
8
  80.0%
Male
2
  20.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
10
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
10
 100.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Fetal Hemoglobin Level
Hide Description Mean fetal hemoglobin calculated to indicate effectiveness of hydroxyurea dose
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hydroxyurea
Hide Arm/Group Description:
Hydroxyurea is given to the patients as per a dosing algorithm.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Percentage
8.3  (5.9)
2.Primary Outcome
Title Fetal Hemoglobin Level
Hide Description Mean fetal hemoglobin calculated to indicate effectiveness of hydroxyurea dose
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hydroxyurea
Hide Arm/Group Description:
Hydroxyurea is given to the patients as per a dosing algorithm.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Percentage
25.1  (6.2)
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Hydroxyurea
Hide Arm/Group Description Hydroxyurea is given to the patients as per a dosing algorithm.
All-Cause Mortality
Hydroxyurea
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Hydroxyurea
Affected / at Risk (%)
Total   3/10 (30.00%) 
Blood and lymphatic system disorders   
Acute chest syndrome   1/10 (10.00%) 
Sickle cell anaemia with crisis   2/10 (20.00%) 
Infections and infestations   
Viral infection   1/10 (10.00%) 
Surgical and medical procedures   
Knee arthroplasty   1/10 (10.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Hydroxyurea
Affected / at Risk (%)
Total   10/10 (100.00%) 
Blood and lymphatic system disorders   
Anaemia   2/10 (20.00%) 
Blood disorder   5/10 (50.00%) 
Lymph node pain   1/10 (10.00%) 
Cardiac disorders   
Dizziness   2/10 (20.00%) 
Dyspnoea   2/10 (20.00%) 
Oedema peripheral   2/10 (20.00%) 
Eye disorders   
Vision blurred   1/10 (10.00%) 
Vitreous floaters   1/10 (10.00%) 
Gastrointestinal disorders   
Diarrhoea   1/10 (10.00%) 
Nausea   3/10 (30.00%) 
Vomiting   2/10 (20.00%) 
General disorders   
Fatigue   2/10 (20.00%) 
Influenza like illness   1/10 (10.00%) 
Pain   8/10 (80.00%) 
Pyrexia   2/10 (20.00%) 
Infections and infestations   
Bronchitis   1/10 (10.00%) 
Upper respiratory tract infection   1/10 (10.00%) 
Investigations   
Alanine aminotransferase increased   2/10 (20.00%) 
Neutrophil count decreased   7/10 (70.00%) 
Platelet count decreased   2/10 (20.00%) 
Musculoskeletal and connective tissue disorders   
Arthralgia   1/10 (10.00%) 
Nervous system disorders   
Headache   4/10 (40.00%) 
Insomnia   1/10 (10.00%) 
Nervous system disorder   1/10 (10.00%) 
Somnolence   1/10 (10.00%) 
Renal and urinary disorders   
Chromaturia   1/10 (10.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough   1/10 (10.00%) 
Skin and subcutaneous tissue disorders   
Dermatitis bullous   1/10 (10.00%) 
Nail discolouration   2/10 (20.00%) 
Pruritus   1/10 (10.00%) 
Rash maculo-papular   3/10 (30.00%) 
Skin disorder   1/10 (10.00%) 
Skin hyperpigmentation   3/10 (30.00%) 
Vascular disorders   
Embolism   1/10 (10.00%) 
Thrombophlebitis superficial   1/10 (10.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Fitzhugh, Courtney
Organization: National Heart Lung and Blood Institute
Phone: +1 301 402 6496
EMail: courtney.fitzhugh@nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier: NCT02225132     History of Changes
Other Study ID Numbers: 140172
14-H-0172
First Submitted: August 23, 2014
First Posted: August 26, 2014
Results First Submitted: July 15, 2019
Results First Posted: August 6, 2019
Last Update Posted: August 6, 2019