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NCT00500539 · ClinicalTrials.gov registry record · Phase 3
Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.
A Phase 3 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 3
- Development phase
- 155
- Enrollment target
NCT00500539: Completed Phase 3 study, sponsored by Novartis.
NCT00500539 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 155 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00500539, a Phase 3 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 155 participants
- Enrollment target
Study Summary
The primary objective of this study is to assess the immunogenic potential of the liquid formulation of omalizumab administered over a period of 6 months in moderate to severe persistent allergic asthma patients 12 years of age or older, with no previous exposure to the drug (omalizumab naïve patients). The secondary objective of this study is to assess the safety of the liquid formulation of omalizumab in the same patients.
Primary Outcome
An assessment of the immunogenic potential of omalizumab liquid was a primary objective of the study, and was based on the results of the human anti-human antibody (HAHA) assays at the end of the follow-up period. A participant was considered potentially HAHA positive if either Fab or Fc was more than 2.0 titer. All values more than 2.0 titer were re-assayed to obtain a confirmatory result. Confirmatory results were used to determine those participants who were HAHA positive.
Interventions
- DRUG omalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2007-07 |
| Est. Completion | 2008-09 |
| Phase | Phase 3 |
What the finished NCT00500539 record still lists
NCT00500539 is an interventional study that assigns participants to a tested intervention. The registered 155 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 (80% lower).
The record links to 0 conditions, and to 1 intervention - of which omalizumab is the first listed.
NCT00500539 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00500539 about?
NCT00500539 is a clinical study titled "Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.". The primary objective of this study is to assess the immunogenic potential of the liquid formulation of omalizumab administered over a period of 6 months in moderate to severe persistent allergic asthma patients 12 years of age or older, with no previous exposure to the drug (omalizumab naïve patien...
What is the current status of trial NCT00500539?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 155 participants. The study started on 2007-07. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00500539?
The interventions under investigation include: omalizumab (DRUG).
Who is sponsoring clinical trial NCT00500539?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00500539's enrollment target sits among peer trials
155 1509th of 2000 higher than 492 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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