NCT07096440Not yet recruiting
Noninterventional Study on Tolerability and Safety of One Strength Updosing With Novo-Helisen Depot House Dust Mites
NOVo-Helisen Depot HoUSe Dust Mites - A Prospective, Multicenter, Noninterventional Clinical Study on the Tolerability and Safety of Short One Strength UP-dosing in Children, Adolescents, and Adults in Daily Practice
Source: ClinicalTrials.gov · Last updated 31 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 105 (estimated)
- First submitted
- 17 Jul 2025
- Start date
- 30 Jul 2025
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Allergopharma GmbH & Co. KG
- Diseases
- Asthma
- NCT number
- NCT07096440
What you commit to
- Study type: Observational
- Planned participants: 105
- From 30 Jul 2025 to the primary completion date, 30 Jun 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Any contraindication according to section 4.3 of the current SmPC for NHD (D.p./D.f.) for the One Strength dose escalation scheme.
Who the study is looking for
- 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.
Age in the registry: 5 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.