Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Cat Dander

• Sponsor: Probelte Pharma S.L.U. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04207697
• Collaborator: (none)
• Enrollment: 50
• Locations: 7
• Anticipated Duration (Months): 34
• Patients Per Site: 7.1
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Rhinoconjunctivitis With or Without Allergic Asthma	Biological: Beltavac® Polymerized with cat dander

Detailed Description

This prospective open multi-centre non-interventional study assess the safety and effectiveness profile of the subcutaneous allergen-specific immunotherapy with Beltavac® Polymerized with cat dander allergic patients (children and adults) in routine medical care. Patients receive a rush schedule administration every month for a year. They attend at least 5 study visits to inform about the adverse reactions, the self reported symptoms and the medication intake.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Cat Dander
• Actual Study Start Date: Dec 1, 2019
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Outcome Measures

Primary Outcome Measures

1. Numbers of treatment-related local and systemic reactions [12 months]

   Number of adverse reactions occurred during the treatment period and classified according to the WAO standards

Secondary Outcome Measures

1. Combined Symptom and Medication Score of Rhinoconjunctivitis [12 months]

   The score will be calculated as a sum of the symptoms score (0-3) and medication score (0-3)

2. Combined Symptom and Medication Score of Asthma [12 months]

   The score will be calculated as a sum of the symptoms score (0-3) and medication score (0-3)

3. Visual analogue Scale Score [12 months]

   Psycometric scale that assesses the global allergic disease discomfort. It is a 10 cm line representing severity from 0:"no symptoms" to 10 "highest level of symptoms"

4. IgE and IgG4 specific quantification [6 and 12 months]

   IgE and IgG4 quantification in serum at baseline, 6 and 12 months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Patients with immunotherapy treatment at the time of inclusion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Campus de la Salud University Hospital	Granada	Andalucía	Spain
2	Ciudad de Jaen Hospital	Jaén	Andalucía	Spain
3	Quirón Campo de Gibraltar Hospital	Palmones	Cádiz	Spain
4	Quirón Malaga Hospital	Málaga	Malaga	Spain
5	Al-lergo Centre Clinic	Barcelona		Spain
6	Bellvitge University Hospital	Barcelona		Spain
7	Alergogranada	Granada		Spain

Sponsors and Collaborators

• Probelte Pharma S.L.U.

Investigators

• Principal Investigator: Carolina Mérida, San Cecilio Universitary Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Probelte Pharma S.L.U.
• ClinicalTrials.gov Identifier: NCT04207697
• Other Study ID Numbers: PRO-BEL-2019-01
• First Posted: Dec 23, 2019
• Last Update Posted: May 25, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 25, 2022