Study to Assess the Safety and Effectiveness of Beltavac®... | NCT03963947

Studies
Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With House Dust Mites

NCT03963947

Sponsor

Alfons Malet i Casajuana

Status

Completed

Last Update Posted

May 25, 2023Actual

Enrollment

97Actual

Phase

Not provided

Conditions

Rhinoconjunctivitis With or Without Allergic Asthma

Interventions

Beltavac® Polymerized with house dust mites

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2019Actual

Primary Completion Date

May 24, 2023Actual

Completion Date

May 24, 2023Actual

First Submitted Date

May 23, 2019

First Submission Date that Met QC Criteria

May 23, 2019

First Posted Date

May 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2023

Last Update Posted Date

May 25, 2023Actual

Name	Class
Probelte Pharma S.L.U.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerised With House Dust Mite in pediatric allergic patients

Detailed Description

This prospective open multi-center non-interventional study assess the safety and effectiveness profile of the subcutaneous allergen-specific immunotherapy with Beltavac polymerized with house dust mite pediatric allergic patients 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

97Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Beltavac® Polymerized with house dust mites	Biological	Adminstration of Beltavac® Polymerized with house dust mites according to the routine clinical practice

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Numbers of treatment-related local and systemic reactions		1 Year

Secondary Outcomes

Measure	Description	Time Frame
Combined symtom and medication score of Rhinoconjunctivitis	The score will be calculated as a sum of the symptoms score (0-3) and medication score (0-3)	1 Year
Combined symtom and medication score of Asthma

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients from 3 to 11 years suffering from a clinically relevant Dermatophagoides farinae and Dermatophagoides pteronyssinus induced allergic rhinitis or rhinoconjunctivitis associated with or not with asthma
Positive skin testing
Positive Serum-Specific IgE determination
Parental or legal representative informed consent
Clinical sintomatology on the inclusion period

Exclusion Criteria:

Patients suffering from acute or chronic infections or inflammations
Patients suffering from uncontrolled and severe 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

Patients from 3 to 11 years, who suffer from allergic rhinitis or rhinoconjunctivitis associated with or not with asthma caused by house dust mites

Sampling Method

Non-Probability Sample