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

Study to Assess the Safety and Effectiveness of Beltavac ® Polymerized With Cat Dander: Condition:   Rhinoconjunctivitis With or Without Allergic Asthma Intervention:   Biological: Beltavac® Polymerized with cat dander Sponsor:   Probelte Pharma S.L.U. Recruiting (Source: ClinicalTrials.gov)

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.



ClinicalTrials.gov Identifier: NCT04207697

Recruitment Status  : Recruiting

First Posted  : December 23, 2019

Last Update Posted  : December 23, 2019

See Contacts and Locations

Sponsor:

Probelte Pharma S.L.U.

Information provided by (Responsible Party):

Probelte Pharma S.L.U.



Study DetailsTabular ViewNo Results PostedDisclaimerHow to Read a Study Record

Study Description

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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

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

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Study Type  : Observational

Estimated Enrollment  : 50 participants

Observational Model: Cohort

Time Perspective: Prospective

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

Estimated Study Start Date  : December 2019

Estimated Primary Completion Date  : September 2021

Estimated Study Completion Date  : October 2021

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Allergic asthma

U.S. FDA Resources



Groups and Cohorts

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Intervention Details:

Biological: Beltavac® Polymerized with cat dander

Adminstration of Beltavac® Polymerized with cat dander according to the routine clinical practice



Outcome Measures

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Primary Outcome Measures  :

Numbers of treatment-related local and systemic reactions [ Time Frame: 1 year ]



Secondary Outcome Measures  :

Combined Symptom and Medication Score of Rhinoconjunctivitis [ Time Frame: 1 year ]

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



Combined Symptom and Medication Score of Asthma [ Time Frame: 1 year ]

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



Visual analogue Scale Score [ Time Frame: 1 year ]

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"



IgE and IgG4 specific quantification [ Time Frame: 1 year ]



Eligibility Criteria

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Information from the National Library of Medicine

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Ages Eligible for Study:  12 Years to 65 Years   (Child, Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

Sampling Method:  Non-Probability Sample

Study Population

Patients aged 12 years or older who suffer from allergic rhinoconjunctivitis caused by cat dander

Criteria

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

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.



Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04207697





Contacts

Contact: Inmaculada Buendía Jiménez, DVM +34 968 858577 inmaculadabuendia@probeltepharma.es



Locations

Spain

University Hospital Campus de la Salud Recruiting

Granada, Andalucía, Spain

Contact: Carolina Mérida Fernández, DM       

Ciudad de Jaen Hospital Not yet recruiting

Jaén, Andalucía, Spain

Contact: Blanca Saenz de San Pedro Morera, DM       

Sponsors and Collaborators

Probelte Pharma S.L.U.

More Information

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Responsible Party: Probelte Pharma S.L.U.

ClinicalTrials.gov Identifier: NCT04207697     History of Changes

Other Study ID Numbers: PRO-BEL-2019-01

First Posted: December 23, 2019    Key Record Dates

Last Update Posted: December 23, 2019

Last Verified: December 2019

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

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