Noninterventional Study on Tolerability and Safety of One Strength Updosing With Novo-Helisen Depot House Dust Mites

ConditionsAllergic Rhinitis Due to House Dust Mite Allergic Conjunctivitis Due to Dermatophagoides Farinae Allergic Conjunctivitis Due to Dermatophagoides Pteronyssinus Allergic Asthma Due to Dermatophagoides Farinae Allergic Asthma Due to Dermatophagoides Pteronyssinus

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age5+

SponsorAllergopharma GmbH & Co. KG

About this trial

The goal of this non-interventional study is to investigate the safety and tolerability of a new simplified up-dosing schedule for Novo-Helisen Depot.

Novo-Helisen Depot is an approved allergen immunotherapy used to treat allergies to house dust mites. For allergen immunotherapy, it is important that the allergen dose is gradually increased, a process known as up-dosing to induce immune tolerance to the allergen. The recently approved One Strength up-dosing scheme for Novo-Helisen Depot allows up-dosing with 6 injections instead of the previously required 14 injections.

The main questions the study aims to answer are:

How is the tolerability and the safety of One Strength up-dosing scheme in daily practice? This study includes approximately 105 patients (children (≥5 years), adolescents, and adults), receiving this treatment as part of their usual care.

Study data on safety and tolerability wil be collected for each patient during the first 8 injection visits.

The study will be conducted at 6-8 study sites in Poland.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent from the patient. For patients under the age of 18, the consent of both parents/legal guardians is also required.

Patients who are eligible for treatment with the One Strength dose escalation scheme of NHD (D.p./D.f.) according to the specifications in the SmPC. These include children (5 to <12 years), adolescents (≥12 to <18 years) and adults (≥18 years) with allergic (IgE-mediated) diseases, such as allergic rhinitis, allergic conjunctivitis, allergic bronchial asthma (see section 4 of the current SmPC)

The treatment decision must precede the decision to participate in the study and must be independent.

Disqualifiers

Any contraindication according to section 4.3 of the current SmPC for NHD (D.p./D.f.) for the One Strength dose escalation scheme.

Trial population

This NIS will enroll a total of 105 patients, including 35 children (aged ≥5 to \< 12 years), 35 adolescents (aged ≥12 to \<18 years), and 35 adults (aged ≥ 18 years). Patient recruitment will be conducted at six to eight allergy-specialized study sites across Poland. Participation in this NIS follows the independent and prior decision by the treating physician and the patient to begin therapy with the One Strength dose escalation scheme of NHD (D.p./D.f.). The indication and use of the One Strength up-dosing scheme of NHD (D.p./D.f.) is based exclusively on the individual therapeutic need.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

Safety of the One Strength dose escalation scheme in daily practice

* Number, incidence, type, intensity and time of occurrence of (serious) adverse events ((S)AEs) * Number, incidence, type, intensity and time of occurrence of (serious) adverse drug reactions ((S)ADRs) * Frequency and intensity of systemic allergic reactions * Proportion of patients who reach the maintenance dose without/with dose adjustment

Time frame

up to study completion, approximately 11 to 20 weeks

Tolerability of the One Strength dose escalation scheme in daily practice

Tolerability will be assessed by both the treating physicians and the patients using a 5-point Likert scale (Likert, 1932) with the following categories: "Very bad," "Bad," "Average," "Good," and "Very good".

Time frame

up to study completion, approximately 11 to 20 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Allergopharma GmbH & Co. KG

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: