Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| inVentiv Health Clinical | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study to Assess the Safety of Cat-PAD in Cat Allergic Paediatric Subjects
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Cat-PAD and Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cat-PAD | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With AEs | To evaluate the safety and tolerability of Cat-PAD in paediatric subjects aged 5 to <12 years. | up to 36 weeks after start of treatment |
Not provided
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lodz | Poland | |||||
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo run-in Followed by Cat-PAD | All participants; received two intradermal doses of placebo (saline) followed by eight intradermal administrations of Cat-PAD. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Study Participants | Overall study participants |
| 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 |
| 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 | Number of Subjects With AEs | To evaluate the safety and tolerability of Cat-PAD in paediatric subjects aged 5 to <12 years. | All subjects enrolled | Posted | Number | participants | up to 36 weeks after start of treatment |
|
|
Overall study (up to 36 weeks after the start of treatment)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo run-in | Placebo run-in |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Clinical Operations | Circassia Ltd | +44 1864 405560 |
Not provided
Not provided
Not provided
Not provided
|
| Tarnów |
| Poland |
| Warsaw | Poland |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| 0 |
| 16 |
| 5 |
| 16 |
| EG001 | Cat-PAD | Active treatment (Cat-PAD) | 2 | 16 | 12 | 16 |
| pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Allergy to animal | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
To avoid disclosures that may affect the proprietary rights of the Sponsor, the Investigator agrees to allow Circassia the opportunity to review all manuscripts and abstracts 60 days prior to submission for publication. Circassia reserves the right to include the report of this study in any regulatory documentation or submission or in any informational materials.