Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Cat Dander
1 other identifier
observational
34
1 country
7
Brief Summary
Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerized With Cat Dander in allergic patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2019
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2019
CompletedFirst Submitted
Initial submission to the registry
December 19, 2019
CompletedFirst Posted
Study publicly available on registry
December 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 9, 2023
CompletedMay 11, 2023
May 1, 2023
3.2 years
December 19, 2019
May 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Numbers of treatment-related local and systemic reactions
Number of adverse reactions occurred during the treatment period and classified according to the WAO standards
12 months
Secondary Outcomes (4)
Combined Symptom and Medication Score of Rhinoconjunctivitis
12 months
Combined Symptom and Medication Score of Asthma
12 months
Visual analogue Scale Score
12 months
IgE and IgG4 specific quantification
6 and 12 months
Interventions
Adminstration of Beltavac® Polymerized with cat dander according to the routine clinical practice
Eligibility Criteria
Patients aged 12 years or older who suffer from allergic rhinoconjunctivitis caused by cat dander
You may qualify if:
- Patients of the age of 12 years and older suffering from a clinically relevant cat dander induced allergic rhinitis or rhinoconjunctivitis associated with or not with asthma
- Positive skin testing
- Positive Serum-Specific IgE determination
- Informed consent
You may not qualify if:
- Patients suffering from acute or chronic infections or inflammations
- Patients suffering from uncontrolled asthma
- Patients with a known autoimmune disease
- Patients with active malignant disease
- Patients requiring beta-blockers
- Patients having any contraindication for the use of adrenaline
- Patients with previous immunotherapy with this allergen or another allergen with cross-reaction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Campus de la Salud University Hospital
Granada, Andalusia, Spain
Ciudad de Jaen Hospital
Jaén, Andalusia, Spain
Quirón Campo de Gibraltar Hospital
Palmones, Cádiz, Spain
Quirón Malaga Hospital
Málaga, Malaga, Spain
Al-lergo Centre Clinic
Barcelona, Spain
Bellvitge University Hospital
Barcelona, Spain
Alergogranada
Granada, Spain
Study Officials
- PRINCIPAL INVESTIGATOR
Carolina Mérida
San Cecilio Universitary Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2019
First Posted
December 23, 2019
Study Start
December 1, 2019
Primary Completion
February 9, 2023
Study Completion
February 9, 2023
Last Updated
May 11, 2023
Record last verified: 2023-05