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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04974970
Other study ID # 2018-02316
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date April 1, 2019
Est. completion date April 19, 2022

Study information

Verified date August 2023
Source University Hospital, Geneva
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this trial is to assess the safety and efficacy of peanut immunotherapy in children and adults with peanut allergy. Participants will receive immunotherapy with peanut every 2 weeks for a period of 3 months.


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Study Design


Intervention

Drug:
Peanut Immunotherapy
Treatment will be injected peanut extract every 2 weeks for a period of 3 months.

Locations

Country Name City State
Switzerland Pediatric allergy unit, Hôpitaux Universitaires de Genève (HUG) Geneva

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Result (positive or negative) and cumulative reaction threshold at 3 months peanut oral food challenge (OFC). An unblinded evaluation of peanut OFC cumulative reaction threshold after 3 months of peanut immunotherapy. 3 months
Secondary Change in serum levels of allergen specific IgE and IgG4 after 6 weeks and 3 months of treatment compared to baseline peanut specific IgE and IgG4 after 3 months of treatment with peanut extract. An evaluation of changes in serum levels of allergen specific IgE and IgG4 after 6 weeks and 3 months of treatment compared to baseline peanut specific IgE and IgG4 after 3 months of treatment with peanut extract. 3 months
Secondary Change in titrated skin prick test after 6 weeks and 3 months of treatment with peanut extract compared to baseline. An evaluation of changes in titrated skin prick tests after 6 weeks and 3 months of treatment with peanut extract compared to baseline. 3 months
Secondary Incidence rate of treatment emergent adverse events during peanut immunotherapy An unblinded evaluation of the safety of peanut immunotherapy as measured by the incidence of treatment-emergent adverse events (AEs and SAEs). 3 months
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