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Hydroxyurea for Children and Young Adults With Sickle Cell Disease and Pulmonary Hypertension

This study has been terminated.
(Low subject accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00350844
First Posted: July 11, 2006
Last Update Posted: May 8, 2013
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.
Information provided by (Responsible Party):
Robert I. Liem, Ann & Robert H Lurie Children's Hospital of Chicago
Results First Submitted: February 18, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Sickle Cell Disease
Pulmonary Hypertension
Intervention: Drug: Hydroxyurea

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study is currently closed to patient accrual at all sites due to poor enrollment, including Children’s Memorial Hospital, Washington University, Johns Hopkins and the Medical College of Wisconsin. The FDA was notified in 2010, and the IND was removed for this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Hydroxyurea Hydroxyurea : 20 mg/kg/day and dose escalating every 2 months until maximum tolerated dose.

Participant Flow:   Overall Study
    Hydroxyurea
STARTED   6 
COMPLETED   5 
NOT COMPLETED   1 
Lost to Follow-up                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Hydroxyurea Hydroxyurea : 20 mg/kg/day and dose escalating every 2 months until maximum tolerated dose.

Baseline Measures
   Hydroxyurea 
Overall Participants Analyzed 
[Units: Participants]
 6 
Age 
[Units: Participants]
 
<=18 years   6 
Between 18 and 65 years   0 
>=65 years   0 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 NA [1] 
[1] Study was terminated due to low enrollment.
Gender 
[Units: Participants]
 
Female   2 
Male   4 
Region of Enrollment 
[Units: Participants]
 
United States   6 


  Outcome Measures

1.  Primary:   Tricuspid Regurgitant Jet Velocity   [ Time Frame: 6 and 12 months after HU therapy begins ]

2.  Secondary:   Compliance   [ Time Frame: Throughout study ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination leading to no data analysis completed.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Robert I. Liem
Organization: Ann and Robert H. Lurie Children's Hospital of Chicago
phone: 312-227-4842
e-mail: Rliem@luriechildrens.org



Responsible Party: Robert I. Liem, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT00350844     History of Changes
Other Study ID Numbers: 12735
First Submitted: July 10, 2006
First Posted: July 11, 2006
Results First Submitted: February 18, 2013
Results First Posted: May 8, 2013
Last Update Posted: May 8, 2013