Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Alternaria Alternata
Observational Prospective Study to Assess the Safety and Effectiveness Profile of Beltavac® Polymerized With Alternaria Alternata
2 other identifiers
observational
65
1 country
13
Brief Summary
Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerized With Alternaria alternata 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 Jun 2018
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 7, 2018
CompletedFirst Submitted
Initial submission to the registry
July 19, 2018
CompletedFirst Posted
Study publicly available on registry
July 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2023
CompletedMay 11, 2023
May 1, 2023
4.6 years
July 19, 2018
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 standard
1 year
Secondary Outcomes (3)
Rhinoconjuntivitis medication intake
1 year
Visual analogue Scale Score
1 year
IgE and IgG4 specific quantification
1 year
Interventions
Adminstration of Beltavac® Polymerized with Alternaria alternata according to the routine clinical practice
Eligibility Criteria
Patients from the age of 5 on, who suffer from allergic rhinoconjunctivitis caused by Alternaria alternata
You may qualify if:
- Patients of the age of 5 years and older suffering from a clinically relevant Alternaria alternata induced allergic rhinitis
- Positive skin testing or IgE determination to the relevant allergen
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Universitary Hospital of Vic
Vic, Barcelona, Spain
Medical Center Fedear
Barcelona, Catalonia, Spain
University Hospital of Torrejon
Torrejón de Ardoz, Madrid, Spain
University Hospital of Cartagena
Cartagena, Murcia, Spain
Clínica de Alergia Mar Jiménez Lara
Talavera de la Reina, Toledo, Spain
Allergo Centre
Barcelona, Spain
Medical Center Cenvi Medic
Barcelona, Spain
Alergomundo
Madrid, Spain
Clinica Torrelodones
Madrid, Spain
Ojeda Clinic
Madrid, Spain
University Hospital Virgen de la Arrixaca
Murcia, 30100, Spain
Reina Sofia Universitary Hospital
Murcia, Spain
Clinica Alergologica Dr Moral
Toledo, Spain
Study Officials
- STUDY DIRECTOR
Inmaculada Buendía Jiménez
Probelte Pharma
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2018
First Posted
July 27, 2018
Study Start
June 7, 2018
Primary Completion
January 20, 2023
Study Completion
January 20, 2023
Last Updated
May 11, 2023
Record last verified: 2023-05