Autopsy report · NCT04056299

Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy

“The study was prematurely terminated by the Sponsor based on difficulties in meeting enrollment goals, especially during the COVID-19 pandemic, and not for reasons relating to any concerns regarding quality, safety, or efficacy.”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 1 year 4 months before it stopped.
• 15 participants enrolled.
• Results were posted on the registry 1 year 2 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

Aimmune Therapeutics, Inc.

Sponsor type

Industry

Conditions

Hen Egg Allergy

Interventions

AR201 powder; Placebo powder

Participants

15

Sites

11

Countries

United States

Trials that died the same way

• Changing Developmental Trajectories Through Early Treatment
  “Participant enrollment was hindered by the COVID-19 pandemic and the study was ultimately terminated.” (86% match in meaning)
• Assessment of the Utility of BIOMONITOR to Identify Atrial Fibrillation (AF) in Ablation Candidates Using Precise AF Detection
  “This study was terminated by the sponsor since study timelines were extended significantly due to slow enrollment, partly influenced by the COVID-19 pandemic.” (85% match in meaning)
• Treatment Resistance Following Anti-cancer Therapies
  “Study terminated due to lack of enrollment that has been compounded by the global COVID-19 pandemic. There were no safety and/or efficacy concerns involved in the decision to stop enrollment.” (85% match in meaning)
• Anti-RSV Study in Chinese Patients (ASCENT)
  “The study was terminated early due to COVID-19-related enrollment disruptions, not as a result of any product safety concerns.” (82% match in meaning)
• A Study to Assess the Therapeutic Effect and Safety of Adjunctive AKST4290 in Subjects With Bullous Pemphigoid
  “The study was prematurely terminated by the Sponsor due to operational challenges stemming from the coronavirus disease 2019 (COVID-19) pandemic, treatment limitations, rarity of the disease, and drug supply considerations.” (81% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.