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Salvage Peanut Oral Immunotherapy Study (SOIT)

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ClinicalTrials.gov Identifier: NCT03251508
Recruitment Status : Enrolling by invitation
First Posted : August 16, 2017
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
The purpose of this trial is to provide salvage peanut oral immunotherapy for patients with peanut allergy.

Condition or disease Intervention/treatment Phase
Peanut Allergy Drug: Peanut OIT Phase 1 Phase 2

Detailed Description:

Salvage Peanut Oral Immunotherapy Study is a single-arm, open label trial of peanut flour with 6 month active treatment and 6 month follow-up on peanut food equivalent.

The first stage with 6 months treatment will involve approximately 3 months of build up phase (desensitization) to a certain maintenance dose ( 300 mg peanut protein) then 3 months of maintenance phase where subjects take daily 300 mg of peanut protein. After that the subjects will start a food equivalent that contains 300 mg of peanut protein only.

During both phases subjects will be monitored for adverse events including gastrointestinal side effects. They will also be monitored for any anaphylaxis or Epipen use. Data regarding compliance with the drug will be collected as well.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Salvage Peanut Oral Immunotherapy Study: A Single-arm, Open Label Trial of Peanut Flour With 6 Month Active Treatment and 6 Month Follow-up
Actual Study Start Date : January 3, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Peanut OIT/food equivalent
Single arm study with all subjects receiving peanut OIT study drug for the initial 6 months followed by an equivalent amount of peanut food for an additional 6 months.
Drug: Peanut OIT
Participants will be given increasing doses of the peanut oral immunotherapy (OIT) study drug every 2 weeks for 3 months up to the 300 mg maintenance dose and will maintain this dose for 3 months. Subjects will then switch to a food equivalent that contains 300 mg of peanut protein for an additional 6 months.
Other Name: Peanut flour




Primary Outcome Measures :
  1. Incidence rate of treatment-emergent adverse events during the 2-stage study sequence (safety) [ Time Frame: 12 months ]
    An unblinded evaluation of the safety of a 2-stage peanut OIT and peanut food equivalent protocol as measured by the incidence of treatment-emergent adverse events (AEs and SAEs).


Secondary Outcome Measures :
  1. Percentage of missed doses during the 2-stage study sequence (compliance) [ Time Frame: 12 months ]
    An unblinded evaluation of patient compliance with a 2-stage peanut OIT and peanut food equivalent protocol as measured by the percentage of doses missed over the entire protocol.

  2. Incidence rate of treatment-emergent adverse events during peanut OIT stage compared to the peanut food equivalent stage (safety) [ Time Frame: 12 months ]
    An unblinded evaluation of the safety of peanut OIT therapy compared to daily peanut food equivalent ingestion as measured by the incidence of treatment-emergent adverse events (AEs and SAEs) during the peanut OIT stage compared to the peanut food equivalent stage.

  3. Percentage of missed doses during the peanut OIT stage compared to the peanut food equivalent stage (compliance) [ Time Frame: 12 months ]
    An unblinded evaluation of patient compliance with peanut OIT therapy compared to daily peanut food equivalent ingestion as measured by the percentage of doses missed during the peanut OIT stage compared to the peanut food equivalent stage.

  4. Incidence rate of emergency epinephrine use during the 2‑stage study sequence (safety) [ Time Frame: 12 months ]
    As epinephrine is typically used only for more severe or potentially life-threatening allergic reactions, its use can be another measure of the safety of a protocol. This outcome involves an unblinded evaluation of the specific incidence of epinephrine use for the treatment of allergic reactions during a 2-stage peanut OIT and peanut food equivalent protocol.

  5. Incidence rate of gastrointestinal adverse events during the 2-stage study sequence (safety) [ Time Frame: 12 months ]
    As GI side effects are the most commonly reported side effect of published oral peanut treatment protocols, this outcome involves an unblinded evaluation of the specific incidence of GI adverse events during a 2-stage peanut OIT and peanut food equivalent protocol.

  6. Incidence rate of withdrawals during the 2-stage study sequence due to gastrointestinal adverse events (safety) [ Time Frame: 12 months ]
    As GI side effects are the most commonly reported side effect of published oral peanut treatment protocols and have been reported to lead to treatment failure and withdrawal, this outcome involves an evaluation of the incidence of study withdrawals specifically due to GI adverse events during a 2-stage peanut OIT and peanut food equivalent protocol.



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Ages Eligible for Study:   1 Year to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who have completed an immunotherapy trial for peanut allergy within the last 6 months and are unable to tolerate ≥ 300mg of peanut.
  • Age 1-65 years of either sex, any race, any ethnicity. Written informed consent from patient or parent/guardian (if < 18 years) with participant's assent.

Exclusion Criteria:

  • Current participation in an interventional study for peanut allergy
  • History of a severe anaphylactic reaction to peanut, defined as hypoxia, hypotension, or neurologic compromise (cyanosis or SpO2 ≤ 92% at any stage, hypotension, confusion, collapse, loss of consciousness, or incontinence)
  • Eosinophilic or other inflammatory (e.g. celiac) gastrointestinal disease
  • Severe asthma (2007 NHLBI Criteria Steps 5 or 6 , Appendix 2)
  • Use of B blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
  • Significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease) which would put the subject at risk for induction of severe food reactions.

Pregnancy or lactation.


Information from the National Library of Medicine

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): NCT03251508


Locations
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Edwin Kim, MD University of North Carolina, Chapel Hill

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03251508     History of Changes
Other Study ID Numbers: 17-0195
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of North Carolina, Chapel Hill:
Peanut

Additional relevant MeSH terms:
Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases