Safety Study of Gleevec® in Children With Pulmonary Hypertension

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. Identifier: NCT00583115
Recruitment Status : Terminated (Unable to enroll subjects)
First Posted : December 31, 2007
Results First Posted : October 29, 2015
Last Update Posted : October 29, 2015
Information provided by (Responsible Party):
Indiana University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pulmonary Hypertension
Intervention: Drug: Gleevec

  Participant Flow

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
Death                1 

  Baseline Characteristics

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
Overall Participants Analyzed 
[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

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

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

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

Responsible Party: Indiana University Identifier: NCT00583115     History of Changes
Other Study ID Numbers: 0702-21
Internally funded ( Other Identifier: Indiana University )
First Submitted: December 20, 2007
First Posted: December 31, 2007
Results First Submitted: July 21, 2015
Results First Posted: October 29, 2015
Last Update Posted: October 29, 2015