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NCT00635089 · ClinicalTrials.gov registry record · Phase 3
Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis
A Phase 3 study, sponsored by Ception Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 190
- Enrollment target
NCT00635089: Completed Phase 3 study, sponsored by Ception Therapeutics.
NCT00635089 is a Phase 3 study that has completed, run by Ception Therapeutics. The registered enrollment target is 190 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00635089, a Phase 3 study, has completed, sponsored by Ception Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 190 participants
- Enrollment target
Study Summary
This study is an open-label study where all subjects will receive active drug, reslizumab. Subjects are able to enter this trial only through completion of study Res-05-0002 (NCT00538434). The goal of the study is to show longer term safety and efficacy in pediatric subjects who have eosinophilic esophagitis.
Primary Outcome
An AE was defined as any adverse experience, including side effect, injury, toxicity, sensitivity reaction, intercurrent illness, or sudden death, whether or not it was considered related to the use of study drug. Treatment emergent adverse events were those that started any time after the administration of the first dose of study drug (at baseline of this study) and before the cessation of study drug. Serious adverse events that occurred any time after the administration of the first dose of st
Interventions
- DRUG reslizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2008-07 |
| Est. Completion | 2012-01 |
| Phase | Phase 3 |
What the finished NCT00635089 record still lists
NCT00635089 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which reslizumab is the first listed.
NCT00635089 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00635089 about?
NCT00635089 is a clinical study titled "Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis". This study is an open-label study where all subjects will receive active drug, reslizumab. Subjects are able to enter this trial only through completion of study Res-05-0002 (NCT00538434). The goal of the study is to show longer term safety and efficacy in pediatric subjects who have eosinophilic e...
What is the current status of trial NCT00635089?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 190 participants. The study started on 2008-07. Estimated completion is 2012-01.
What interventions are being tested in trial NCT00635089?
The interventions under investigation include: reslizumab (DRUG).
Who is sponsoring clinical trial NCT00635089?
This trial is sponsored by Ception Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00635089's enrollment target sits among peer trials
190 1402nd of 2000 higher than 593 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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