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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| Tanox | INDUSTRY |
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omalizumab | Drug | The liquid formulation of omalizumab was packaged in a pre-filled safety syringe containing either 75 mg (0.5ml) or 150 mg (1.0 ml) of drug. The syringes were clearly marked so that the health care provider could differentiate between the 75 mg or 150 mg syringe. |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period | 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. | 16 weeks after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Bardelas, MD | Allergy and Asthma center of North Carolina, PA, High Point, NC 27262 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergy & Immunology Associates, Ltd | Scottsdale | Arizona | AZ 85251 | United States | ||
| California Allergy and Asthma Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24028677 | Derived | Somerville L, Bardelas J, Viegas A, D'Andrea P, Blogg M, Peachey G. Immunogenicity and safety of omalizumab in pre-filled syringes in patients with allergic (IgE-mediated) asthma. Curr Med Res Opin. 2014 Jan;30(1):59-66. doi: 10.1185/03007995.2013.844115. Epub 2013 Oct 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Omalizumab | The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period (24 Weeks) |
|
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| 24 weeks treatment period + 4 weeks for following up participants |
| Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period | 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). | 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) |
| Palmdale |
| California |
| CA 93551 |
| United States |
| Allergy Associates Medical Group, Inc, | San Diego | California | CA 92120 | United States |
| Bensch Research Associates | Stockton | California | CA 95207 | United States |
| 1st Allergy and Clinical Research Center | Centennial | Colorado | CO 80112 | United States |
| Innovative Research of West Florida, Inc. | Largo | Florida | FL 33770 | United States |
| Georgia Pollen | Albany | Georgia | GA 31707 | United States |
| Kansas City Allergy & Asthma | Overland Park | Kansas | 66210 | United States |
| Asthma and Allergy Specialists, PA | Minneapolis | Minnesota | MN 55402 | United States |
| : The Clinical Research Center, LLC | St Louis | Missouri | MO 63141 | United States |
| Allergy, Asthma and Clinical Immunology | Brick | New Jersey | NJ 08724 | United States |
| Asthma & Allergy Research of NJ, Inc. | Mount Laurel | New Jersey | NJ 08054 | United States |
| Nassau Chest Pysicians, PC | Massapequa | New York | NY 11758 | United States |
| Allergy and Asthma Center of NC, PA | High Point | North Carolina | NC 27262 | United States |
| Allergy Center at Brookstone | Columbus | Ohio | OH 31904 | United States |
| Toledo Center for Clinical Research | Sylvania | Ohio | OH 43650 | United States |
| Asthma and Allergy Center | Toledo | Ohio | OH 43617 | United States |
| The Corvallis Clinic, PC | Corvallis | Oregon | OR 97330 | United States |
| Allergy, Asthma & Dermatology Research Center | Lake Oswego | Oregon | OR97037 | United States |
| Clinical Research Institute of Southern Oregon, PC | Medford | Oregon | OR 97504 | United States |
| Allergy & Asthma Specialists, PC | Blue Bell | Pennsylvania | PA 19422 | United States |
| Asthma Allergy & Pulmonary Associates, PC | Philadelphia | Pennsylvania | PA 19107 | United States |
| AAPRI Clinical Research Institute | Providence | Rhode Island | RI 02906 | United States |
| North Texas Institute for Clinical Trials | Fort Worth | Texas | TX 76132 | United States |
| Allergy and Asthma Associates | Houston | Texas | TX 77054 | United States |
| Clinical Trials of North Houston | Houston | Texas | TX 77070 | United States |
| Novartis Investigative Site, | Buenos Aires | Argentina |
| Novartis Investigative Site | Buenos Aires | Argentina |
| Novartis Investigative Site, | Corrientes | Argentina |
| Novartis Investigative Site, | Mendoza | Argentina |
| Novartis Investigator site | Nuremberg | Germany |
| COMPLETED |
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| NOT COMPLETED |
|
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| Follow-up Period (16 Weeks) |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Omalizumab | The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period | 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. | 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. | Posted | Number | participants | 16 weeks after last dose |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period | 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. | 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. | Posted | Dec 2010 | Number | participants | 24 weeks treatment period + 4 weeks for following up participants |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period | 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). | 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. | Posted | Dec 2010 | Number | participants | 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) |
|
|
Treatment period AEs were collected from first treatment dose until 28 days post last treatment dose (28 weeks total). Follow-up period AEs defined as AEs that began after 28 days post last treatment dose until the end of the follow-up (12 weeks total).
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omalizumab Treatment Period | The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used. | 14 | 155 | 74 | 155 | ||
| EG001 | Omalizumab Follow up Period | Participants were assessed at 16 weeks after the last dose of study drug | 1 | 148 | 34 | 148 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Bronchiectasis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Post procedural swelling | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis viral | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial; or the publication of the trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| Administrative problems |
|
| Death |
|
| Protocol Deviation |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| Fc HAHA Positive - Negative at baseline |
|
| Fc HAHA Positive - Positive at baseline |
|
| Fc HAHA Positive - Missing at baseline |
|
| Fab and/or Fc HAHA Positive - Fab and Fc HAHA -Ve |
|
| Missing at baseline |
|
|
|