Peanut Oral Immunotherapy in Children: IMPACT Follow Up Study
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|ClinicalTrials.gov Identifier: NCT03345160|
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : August 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Treatment Efficacy||Drug: Peanut Flour||Phase 2|
This study will enroll up to 20 subjects aged 4-9 years old who were enrolled in the placebo arm of the IMPACT study.
Once subjects have completed participation in the IMPACT study, subjects will be offered the option of participating in this open label, peanut oral immunotherapy study.
After the informed consent has been signed, subjects will undergo an initial dose escalation to peanut protein to establish the starting dose for the build-up phase. The starting dose of peanut protein for the build-up phase will be the highest tolerated dose during the initial dose escalation. The subject will return to the study site and the first starting dose of peanut protein will be given under observation. Subjects will be sent home with doses of peanut protein to administer at home.
Subject will return every 2 weeks for dose adjustments. Once subjects have tolerated a dose under observation, subjects will then continue dosing at home with OIT and return to the research unit every 2 weeks for a 1-step dose escalation to a maximum daily dose of 1000 mg. Participants who do not reach the 1000mg dose by 40-weeks of build-up phase may enter the maintenance phase at their highest tolerated dose.
When subjects reach their maximum tolerated dose of either 1000 mg per day, or the maximum tolerated dose during the 40 weeks of the build-up phase, subjects will enter the maintenance phase. Subjects will continue daily dosing of peanut protein at the maximum tolerated dose during the 12-week maintenance phase.
At the end of the maintenance phase, subjects will undergo an open peanut oral food challenge to a maximum of 4000 mg of peanut protein to determine individualized guidelines for the introduction of peanut into the subject's diet based on the outcome of the open peanut challenge The primary objective of this protocol is to provide open label peanut oral immunotherapy (OIT) for those subjects who received placebo treatment in the IMPACT Study .
Secondary objectives will include:
1. Efficacy of the treatment, as defined by an end of treatment oral peanut challenge.
Safety, as measured by the incidence of adverse events and the proportion of subjects who discontinue treatment due to adverse events
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open Label crossover|
|Masking:||None (Open Label)|
|Official Title:||Open Label Peanut Oral Immunotherapy in Children: IMPACT Follow Up Study|
|Actual Study Start Date :||April 27, 2018|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Experimental: Peanut Flour: Open label peanut OIT
This is an open label treatment for subjects who had previously received placebo treatment in a prior peanut OIT study
Drug: Peanut Flour
open label oral immunotherapy
Other Name: Peanut Oral Immunotherapy
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: up to 52 weeks ]
- Amount of peanut protein tolerated at the end-of-treatment peanut challenge [ Time Frame: up to 52 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03345160
|Contact: Kim Mudd, RNfirstname.lastname@example.org|
|Contact: Theresa Gagen-Hursey, CPNPemail@example.com|
|United States, Maryland|
|Baltimore, Maryland, United States, 21287|
|Contact: Robert+ Wood, MD 410-955-5883 pediatricallegy@JHMI.edu|
|Contact: Kim Mudd, RN 410-502-1711 firstname.lastname@example.org|
|Principal Investigator:||Robert Wood, MD||Johns Hopkins School of Medicine|