Trial Outcomes & Findings for Safety Study of Gleevec® in Children With Pulmonary Hypertension (NCT NCT00583115)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

6 months

Results posted on

2015-10-29

Participant Flow

Participant milestones

Participant milestones
Measure	Gleevec Drug taken orally 260mg/M2/day once per day Gleevec: 260 mg/M2/day, given once daily by mouth
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Gleevec Drug taken orally 260mg/M2/day once per day Gleevec: 260 mg/M2/day, given once daily by mouth
Overall Study Death	1

Baseline Characteristics

Safety Study of Gleevec® in Children With Pulmonary Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gleevec n=1 Participants Drug taken orally 260mg/M2/day once per day Gleevec: 260 mg/M2/day, given once daily by mouth
Age, Customized Age 8-18 years	1 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Unable to measure safety and tolerability as the participant died prior to study completion. Laboratory evaluations not able to be measured as participant died. Physical examination, Echocardiographic and adverse events not able to be measured as participant died Unable to measure 6 minute walk test as participant died prior to study completion.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: The only participant died prior to study completion. Unable to measure pulmonary artery pressure and vascular resistance as only participant died prior to study completion. Unable to measure time to clinical worsening as only participant died. Survival should be counted as 0.

Outcome measures

Outcome data not reported

Adverse Events

Gleevec

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gleevec n=1 participants at risk Drug taken orally 260mg/M2/day once per day Gleevec: 260 mg/M2/day, given once daily by mouth
Cardiac disorders Death	100.0% 1/1 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Ronald Mark Payne MD

Indiana University

Phone: 317-278-6329

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place