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Extension Study for Patients Entered Into Study Infacort 003

NCT02733367 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-11-05

Study results available
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Summary

A Phase 3, open-label, single-group, non-randomised, observational study of the safety and biochemical disease control of Infacort® in neonates, infants and children with adrenal insufficiency and congenital adrenal hyperplasia who had completed study Infacort 003. All subjects who had satisfactorily completed study Infacort 003 were offered the opportunity to take part in Infacort 004.

Conditions

Interventions

DRUG

Infacort®

Infacort® is a dry granule formulation of hydrocortisone stored in capsules available in different strengths (0.5, 1.0, 2.0 and 5.0 mg).

Sponsors & Collaborators

  • Neurocrine UK Limited

    lead INDUSTRY

Principal Investigators

  • Wiegand · Charite University, Berlin, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-03-04
Primary Completion
2018-08-10
Completion
2018-08-10

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 NCT02733367 on ClinicalTrials.gov