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Treatment of Adrenal Insufficiency in Children

NCT02720952 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-05-04

Study results available
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Summary

The study will be conducted in a total of 24 subjects before their 6th birthday, requiring replacement therapy for adrenal insufficiency due to either CAH, primary adrenal failure or hypopituitarism.

The study will consist of three consecutive cohorts. Cohort 1 will include 12 subjects aged between 2 and \< 6 years. If no safety concerns emerge, then 6 subjects aged 28 days to \<2 years will be enrolled (Cohort 2). A review of accumulated data will be undertaken and only if again no safety concerns emerge, then 6 neonates aged from birth to \<28 days will be enrolled (Cohort 3).

The decision to continue after each cohort will be based on the recommendation of an Independent Data Monitoring Committee (IDMC).

Conditions

Interventions

DRUG

Infacort®

dry granule formulation of hydrocortisone

Sponsors & Collaborators

  • Treatment of Adrenal Insufficiency in Neonates consortium (TAIN)

    collaborator UNKNOWN

  • Neurocrine UK Limited

    lead INDUSTRY

Principal Investigators

  • Susanna Wiegand, MD · Charité-Universitätsmedizin Berlin, CVK

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Week
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02720952 on ClinicalTrials.gov