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NCT01020747 · ClinicalTrials.gov registry record · Phase 1
Bevacizumab for Treatment of Recurrent Respiratory Papillomatosis (RRP)
A Phase 1 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01020747: Completed Phase 1 study, sponsored by Massachusetts General Hospital.
NCT01020747 is a Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01020747, a Phase 1 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This phase I single center open labeled study is planned to assess the safety and tolerability of bevacizumab for treating patients with bilateral Recurrent Respiratory Papillomatosis (RRP). Approximately 20 patients will receive bevacizumab directly injected into the vocal folds. Patients who enroll in the protocol will be injected with bevacizumab in one vocal fold that represents the more diseased of the two folds. A sham injection with saline will be administered to the other vocal fold as the control. This therapy will be administered once every 6 ± 1 week for 6 months, with the same vocal fold selected for the initial treatment always getting the drug injection. The investigator will also treat lesions by laser photoangiolysis of both vocal folds using the 532 nm potassium-titanyl-phosphate (KTP) laser.
Primary Outcome
Prior to each treatment,the area of reappearance of disease was measured and the % change from baseline was calculated. The change was then added to the % change from the previous treatment to generate a cumulative total % change of reappearance of RRP from baseline. The additive nature of this parameter resulted in % greater than 100% if the area of vocal fold affected by the RRP increased over the baseline measurement.
Interventions
- DRUG Saline
- DRUG Avastin® (bevacizumab)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2009-11 |
| Est. Completion | 2011-03 |
| Phase | Phase 1 |
What the finished NCT01020747 record still lists
NCT01020747 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.
NCT01020747 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01020747 about?
NCT01020747 is a clinical study titled "Bevacizumab for Treatment of Recurrent Respiratory Papillomatosis (RRP)". This phase I single center open labeled study is planned to assess the safety and tolerability of bevacizumab for treating patients with bilateral Recurrent Respiratory Papillomatosis (RRP). Approximately 20 patients will receive bevacizumab directly injected into the vocal folds. Patients who enrol...
What is the current status of trial NCT01020747?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2009-11. Estimated completion is 2011-03.
What interventions are being tested in trial NCT01020747?
The interventions under investigation include: Saline (DRUG), Avastin® (bevacizumab) (DRUG).
Who is sponsoring clinical trial NCT01020747?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01020747's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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