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Dupilumab Therapy for EGIDs

ConditionEosinophilic Gastrointestinal Disorders (EGIDs)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorChildren's Hospital of Fudan University

About this trial

This is a single-center observational study to investigate the efficacy and tolerability of dupilumab in children with refractory eosinophilic gastrointestinal disorders.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis of Refractory Peptic Ulcers

with Refractory Eosinophilic Gastrointestinal Disorders

Disqualifiers

with Active Helicobacter pylori infection at present.

with Inflammatory bowel disease

with Parasite infection

with Cancer

Trial population

Children diagnosed with refractory eosinophilic gastrointestinal disorders who were seen at the Children's hospital of Fudan university who met the inclusion and exclusion criteria would be enrolled in this study.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Dupilumab - Standard Dose

    Drug

    Dose: For patients with weight ≥ 15kg but \< 30kg, take 200mg each time, every two weeks; for those with weight ≤ 30kg but \< 60kg, take 300mg each time, every two weeks; for those with weight ≥ 60kg, take 300mg each time, once a week.

  • subcutaneous injection

    Device

    Dose: For patients with weight ≥ 15kg but \< 30kg, take 200mg each time, every two weeks; for those with weight ≤ 30kg but \< 60kg, take 300mg each time, every two weeks; for those with weight ≥ 60kg, take 300mg each time, once a week.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: The patient is over 1 year old; for those who do not respond to conventional treatments (proton pump2 interventions

Trial outcomes

Primary outcomes

1

Endoscopic response rate

The ulcer reaches stage S (healed) or stage H (healing period), or the ulcer area has decreased by more than 50%.

Time frame
week12, week26, week52

Secondary outcomes

1

Relative Change of Peak Eosinophil Counts in the Stomach

We will determine the relative change from baseline in the peak eosinophil count in the five high-power fields (HPFs) with the highest eosinophil density in the antrum and/or body of the stomach after intervention.

Time frame
week12，week26，week52

Other outcomes

1

Adverse event

The rate of the potential adverse events were monitored during the intervention.

Time frame
within one year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital of Fudan University

Lead sponsor

Source ClinicalTrials.gov
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