Phase 2 Completed N=50 Treatment

Pilot Study Using Avastin and Gleevec to Treat the Progression of Intraluminal Pulmonary Vein Stenosis

Pulmonary Veno Occlusive Disease

Source: ClinicalTrials.gov NCT00891527 ↗

Enrolled (actual)

Serious AEs

20.8%

Results posted

May 2017

Primary outcomePrimary: Number of Patients With Survival at 48 Weeks — 42 Participants

Summary

The objective of this study is to conduct a pilot study using biologic agents Avastin and Gleevec to treat progression of multivessel intraluminal pulmonary vein stenosis in children.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Survival at 48 Weeks	42	—
SECONDARY Number of Patients With Disease Progression at 48 Weeks	5	—
SECONDARY Number of Patients With Disease Stabilization at 48 Weeks	15	—

Eligibility Criteria

Eligibility Criteria: (Both groups)

Evidence of intraluminal pulmonary vein stenosis in > 1 vessel
Evidence of myofibroblast neo-proliferation, if biopsies were obtained
Acceptable organ function includes:

Creatinine or = 1,500/mm3, Hemoglobin > or = 10g/dl, Platelets > or = 100,000/mm3.

Group A Eligibility Criteria: (begin treatment with Gleevec® only)

Significant concomitant congenital heart defect
Disease severity for each vessel Category 5 or lower or Category 6 or 7 in no more than 1 vessel

Group B Eligibility Criteria: (begin treatment with Gleevec® and Avastin®)

Primary PVS (i.e. without concomitant congenital heart defect or lung disease)
Significant concomitant lung disease
Patients with PVS and underlying CHD who have category 6 or 7 disease in at least 2 of their pulmonary veins even after surgical or cath-based interventions.
Accepted organ function includes:

Urine protein < 1

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00891527). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.