NCT03963947

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2023

Completed
Last Updated

May 25, 2023

Status Verified

May 1, 2023

Enrollment Period

4 years

First QC Date

May 23, 2019

Last Update Submit

May 24, 2023

Conditions

Rhinoconjunctivitis With or Without Allergic Asthma

Outcome Measures

Primary Outcomes (1)

  • Numbers of treatment-related local and systemic reactions

    1 Year

Secondary Outcomes (4)

  • Combined symtom and medication score of Rhinoconjunctivitis

    1 Year

  • Combined symtom and medication score of Asthma

    1 Year

  • Visual analogue Scale Score

    1 Year

  • IgE and IgG4 specific quantification

    1 Year

Interventions

Beltavac® Polymerized with house dust mitesBIOLOGICAL

Adminstration of Beltavac® Polymerized with house dust mites according to the routine clinical practice

Eligibility Criteria

Age3 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Teknon Medical Center

Barcelona, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Allergy Service in Teknon Medical Center

Study Record Dates

First Submitted

May 23, 2019

First Posted

May 28, 2019

Study Start

June 1, 2019

Primary Completion

May 24, 2023

Study Completion

May 24, 2023

Last Updated

May 25, 2023

Record last verified: 2023-05

Locations

ES(1)