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NCT00215046 · ClinicalTrials.gov registry record · Phase 2
Vinblastine and Methotrexate in Children With Pulmonary Vein Stenosis
A Phase 2 study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
NCT00215046 is a Phase 2 study that has completed, run by Boston Children's Hospital. The registered enrollment target is 28 participants.
The verdict
NCT00215046, a Phase 2 study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
Study Summary
To evaluate the efficacy of the chemotherapeutic agents vinblastine and methotrexate in the treatment of two groups of children with multivessel pulmonary vein stenosis. Group 1 will contain children with multivessel pulmonary vein stenosis who do not have structural heart disease, and Group 2 will consist of children with multivessel pulmonary vein stenosis and concomitant structural heart disease. The primary outcome variable for efficacy is patient status one year after the start of treatment, where status is classified as either failure or success. Failure is defined as death or evidence of progressive obstruction at any time over the course of treatment as defined in the protocol. Success constitutes complete or partial response to treatment or stability of disease. Secondary outcome variables for efficacy are survival, time from diagnosis of pulmonary vein stenosis until failure, and change in patient classification on a scale measuring the severity of the obstructive disease. 1.2 To assess the safety of vinblastine and methotrexate in the treatment of multivessel pulmonary vein stenosis. The primary outcome variable for safety is any occurrence of toxicity related to the administration of the chemotherapeutic agents over the treatment period.
Interventions
- DRUG Methotrexate
- DRUG Vinblastine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2000-03 |
| Est. Completion | 2006-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00215046
The ClinicalTrials.gov registry entry for NCT00215046 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Methotrexate is the first listed.
NCT00215046 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00215046 about?
NCT00215046 is a clinical study titled "Vinblastine and Methotrexate in Children With Pulmonary Vein Stenosis". To evaluate the efficacy of the chemotherapeutic agents vinblastine and methotrexate in the treatment of two groups of children with multivessel pulmonary vein stenosis. Group 1 will contain children with multivessel pulmonary vein stenosis who do not have structural heart disease, and Group 2 will ...
What is the current status of trial NCT00215046?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2000-03. Estimated completion is 2006-10.
What interventions are being tested in trial NCT00215046?
The interventions under investigation include: Methotrexate (DRUG), Vinblastine (DRUG).
Who is sponsoring clinical trial NCT00215046?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
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