Noninterventional Study on Tolerability and Safety of One Strength Updosing With Novo-Helisen Dep… (NCT07096440) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Noninterventional Study on Tolerability and Safety of One Strength Updosing With Novo-Helisen Depot House Dust Mites
105 participantsStarted 2025-07-30
Plain-language summary
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.
Who can participate
Age range
5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Any contraindication according to section 4.3 of the current SmPC for NHD (D.p./D.f.) for the One Strength dose escalation scheme.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety of the One Strength dose escalation scheme in daily practice
Timeframe: up to study completion, approximately 11 to 20 weeks
2
Tolerability of the One Strength dose escalation scheme in daily practice
Timeframe: up to study completion, approximately 11 to 20 weeks