Novel Dose Adjustment Schedule for Late Injection in SCIT in AR
NCT ID: NCT04929093
Last Updated: 2021-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
102 participants
INTERVENTIONAL
2020-06-11
2021-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Novel dose adjustment schedule
The patients in this group had late injections of more than 16 weeks in maintenance period, and restarted SCIT with novel dose adjustment schedule.
Novel dose adjustment of Alutard SQ
novel dose adjustment schedule means directly reaching dose of Vial 4, 10,000 SQ
Conventional dose adjustment
The patients in this group had late injections of more than 16 weeks in maintenance period, and restarted SCIT with conventional dose adjustment schedule.
conventional dose adjustment of Alutard SQ
conventional dose adjustment schedule means restarting from dose of Vial 1, 10 SQ
Continuous cluster SCIT schedule
The subjects had a routine cluster SCIT schedule without interrupted period.
Routine continuous cluster of Alutard SQ
Patient receiving continuous cluster SCIT for DM during the same period
Interventions
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Novel dose adjustment of Alutard SQ
novel dose adjustment schedule means directly reaching dose of Vial 4, 10,000 SQ
conventional dose adjustment of Alutard SQ
conventional dose adjustment schedule means restarting from dose of Vial 1, 10 SQ
Routine continuous cluster of Alutard SQ
Patient receiving continuous cluster SCIT for DM during the same period
Eligibility Criteria
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Inclusion Criteria
* (2) only had a positive response to Der p and Der f but no other inhalant allergens based on EUROline Allergy Diagnostics (Beijing Oumeng Biotechnology Co., Ltd., Beijing, China). Meanwhile at least Der p -specific IgE (sIgE) in serum of was ≥ 0.7 kU/l (CAP Pharmacia, Uppsala, Sweden) using ImmunoCAP system (Pharmacia, Uppsala, Sweden) regardless of the result of Der p -specific IgE in serum;
* (3) had reached cluster SCIT maintenance period and the overall treatment time was more than 1 year but less than 2 years;
* (4) hope to continue to complete the entire treatment and have good compliance.
Exclusion Criteria
* (2) had Grade II or above systemic adverse reactions occurred in the past SCIT period.
5 Years
53 Years
ALL
No
Sponsors
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Beijing Tongren Hospital
OTHER
Responsible Party
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Principal Investigators
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Luo Zhang
Role: PRINCIPAL_INVESTIGATOR
Beijing Tongren Hospital, China
Locations
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Beijing Tongren Hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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TR-SIT-16w
Identifier Type: -
Identifier Source: org_study_id
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