Trial · NCT00500539
Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.
NCT00500539, Phase 3, Completed, Novartis; results first posted 2011-04-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation. Trials, record NCT00500539. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00500539
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.
- NCT number
- NCT00500539
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 155 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Asthma
- Interventions
- omalizumab
- First posted
- 2007-07-12
- Last updated
- 2011-06-02
- Results first posted
- 2011-04-27
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period | 16 weeks after last dose | 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. |
| Secondary | Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period | 24 weeks treatment period + 4 weeks for following up participants | The assessment of safety was based on the number of patients with AEs (mild, moderate and severe) and SAEs. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. The duration of the treatment period was 24 weeks, but patients were followed for an additional 4 weeks, so that the total duration of the treatment period for purposes of AE reporting was 28 weeks. |
| Secondary | Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period | Last 12 weeks of the follow-up period (initial 4 weeks of the follow-up period were included in the treatment period for AE reporting) | The assessment of safety was based on the number of patients with AEs (mild, moderate and severe) and SAEs. According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. The duration of the follow-up period was 16 weeks, but for purposes of AE reporting the follow-up period was 12 weeks (as the first 4 weeks of follow-up were included in the treatment period). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period | 16 weeks after last dose | The Safety Population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not. The analysis was done on total number of patients who had follow-up HAHA sample taken. | participants | NUMBER |
| SECONDARY | Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period | 24 weeks treatment period + 4 weeks for following up participants | The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not. | participants | NUMBER |
| SECONDARY | Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period | Last 12 weeks of the follow-up period (initial 4 weeks of the follow-up period were included in the treatment period for AE reporting) | The safety population consisted of all patients that received any part of a dose of study drug and had any post-baseline assessment, whether scheduled or not. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period | Follow-up Period | Fab HAHA Positive - Negative at baseline | 0 | participants | |
| The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period | Follow-up Period | Fab HAHA Positive - Positive at baseline | 0 | participants | |
| The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period | Follow-up Period | Fab HAHA Positive - Missing at baseline | 0 | participants | |
| The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period | Follow-up Period | Fc HAHA Positive - Negative at baseline | 0 | participants | |
| The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period | Follow-up Period | Fc HAHA Positive - Positive at baseline | 0 | participants | |
| The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period | Follow-up Period | Fc HAHA Positive - Missing at baseline | 0 | participants | |
| The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period | Follow-up Period | Fab and/or Fc HAHA Positive - Fab and Fc HAHA -Ve | 0 | participants | |
| The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period | Follow-up Period | Missing at baseline | 0 | participants | |
| Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period | Treatment Period | Participants with AEs during the treatment period | 124 | participants | |
| Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period | Treatment Period | Mild AEs | 25 | participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period (24 Weeks) | STARTED | Omalizumab | 155 | |
| Treatment Period (24 Weeks) | COMPLETED | Omalizumab | 140 | |
| Treatment Period (24 Weeks) | NOT COMPLETED | Omalizumab | 15 | |
| Follow-up Period (16 Weeks) | STARTED | Omalizumab | 148 | |
| Follow-up Period (16 Weeks) | COMPLETED | Omalizumab | 136 | |
| Follow-up Period (16 Weeks) | NOT COMPLETED | Omalizumab | 12 |
Source ClinicalTrials.gov
Adverse events44
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gastroenteritis viral | Infections and infestations | Omalizumab Treatment Period | 8 | 155 | |
| other | Gastroenteritis viral | Infections and infestations | Omalizumab Follow up Period | 0 | 148 | |
| other | Nasopharyngitis | Infections and infestations | Omalizumab Treatment Period | 15 | 155 | |
| other | Nasopharyngitis | Infections and infestations | Omalizumab Follow up Period | 3 | 148 | |
| other | Sinusitis | Infections and infestations | Omalizumab Treatment Period | 27 | 155 | |
| other | Sinusitis | Infections and infestations | Omalizumab Follow up Period | 12 | 148 | |
| other | Upper respiratory tract infection | Infections and infestations | Omalizumab Treatment Period | 18 | 155 | |
| other | Upper respiratory tract infection | Infections and infestations | Omalizumab Follow up Period | 6 | 148 | |
| other | Headache | Nervous system disorders | Omalizumab Treatment Period | 13 | 155 | |
| other | Headache | Nervous system disorders | Omalizumab Follow up Period | 1 | 148 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Omalizumab Treatment Period | ||
| Total, all-cause mortality | Omalizumab Follow up Period | ||
| Total, other adverse events | Omalizumab Treatment Period | 74 | 155 |
| Total, other adverse events | Omalizumab Follow up Period | 34 | 148 |
| Total, serious adverse events | Omalizumab Treatment Period | 14 | 155 |
| Total, serious adverse events | Omalizumab Follow up Period | 1 | 148 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24028677 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Omalizumab Treatment Period vs Omalizumab Follow up Period: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00500539
GET https://conductscience.org/api/trials/v1/NCT00500539/results?page=2