Safety Study of Gleevec® in Children With Pulmonary Hypertension

This study has been terminated.
(Unable to enroll subjects)
Information provided by (Responsible Party):
Indiana University Identifier:
First received: December 20, 2007
Last updated: September 28, 2015
Last verified: September 2015
Results First Received: July 21, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pulmonary Hypertension
Intervention: Drug: Gleevec

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

Drug taken orally 260mg/M2/day once per day

Gleevec: 260 mg/M2/day, given once daily by mouth

Participant Flow:   Overall Study
STARTED     1  
Death                 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.
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Reporting Groups

Drug taken orally 260mg/M2/day once per day

Gleevec: 260 mg/M2/day, given once daily by mouth

Baseline Measures
Number of Participants  
[units: participants]
Age, Customized  
[units: years]
Age 8-18 years     1  
[units: participants]
Female     0  
Male     1  
Region of Enrollment  
[units: participants]
United States     1  

  Outcome Measures
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1.  Primary:   1) Safety and Tolerability as Determined by Laboratory Evaluation, Physical Examination, Echocardiographic Analysis, and Adverse Events, and 2) Efficacy as Determined by an Increase in the Non-encouraged 6 Minute Walk Test From Baseline.   [ Time Frame: 6 months ]

2.  Secondary:   1) Decrease in Pulmonary Artery Pressures and Vascular Resistance as Determined by Cardiac Catheterization, 2) Time to Clinical Worsening,3) Survival.   [ Time Frame: 6 months ]

  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Ronald Mark Payne MD
Organization: Indiana University
phone: 317-278-6329

No publications provided

Responsible Party: Indiana University Identifier: NCT00583115     History of Changes
Other Study ID Numbers: 0702-21, Internally funded
Study First Received: December 20, 2007
Results First Received: July 21, 2015
Last Updated: September 28, 2015
Health Authority: United States: Food and Drug Administration