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Long-term Safety Study of Chronocort in the Treatment of Participants With Congenital Adrenal Hyperplasia
Sponsor: Immedica Pharma AB
Summary
This phase III study is an open-label extension study to be conducted at approximately 21 investigational sites across 3 countries. The study will evaluate the long-term safety and tolerability of Chronocort in participants aged 16 years and over when used as treatment for Congenital Adrenal Hyperplasia (CAH).
Official title: A Phase 3 Open-Label Extension Study to Evaluate the Long-term Safety and Tolerability of Chronocort in the Treatment of Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
76
Start Date
2022-04-01
Completion Date
2026-01-15
Last Updated
2026-06-18
Healthy Volunteers
No
Conditions
Interventions
Chronocort
Hydrocortisone modified-release capsule 5 mg and 10 mg
Locations (21)
Neurocrine Investigational Site in California
Los Angeles, California, United States
Neurocrine Investigational Site in California
Orange, California, United States
Neurocrine Investigational Site in Florida
Jacksonville, Florida, United States
Neurocrine Investigational Site in Iowa
Iowa City, Iowa, United States
National Institutes of Health Center
Bethesda, Maryland, United States
Neurocrine Investigational Site in Michigan
Ann Arbor, Michigan, United States
Neurocrine Investigational Site in Minnesota
Rochester, Minnesota, United States
Neurocrine Investigational Site in Nevada
Las Vegas, Nevada, United States
Neurocrine Investigational Site in Texas
Dallas, Texas, United States
Neurocrine Investigational Site in Washington
Seattle, Washington, United States
Neurocrine Investigational Site in Wisconsin
Milwaukee, Wisconsin, United States
Neurocrine Investigational Site in Caen
Caen, France
Neurocrine investigational Site in Lyon
Lyon, France
Neurocrine Investigational Site in Paris
Paris, France
Neurocrine Investigational Site in Pessac
Pessac, France
Neurocrine Investigational Site in Toulouse (Children's hospital)
Toulouse, France
Neurocrine Investigational Site in Toulouse
Toulouse, France
Neurocrine Investigational Site in Asahi-ku
Yokohama, Kanagawa, Japan
Neurocrine Investigational Site in Yushima
Bunkyō-Ku, Tokyo, Japan
Neurocrine Investigational Site in Okura
Setagaya-Ku, Tokyo, Japan
Neurocrine Investigational Site in Toyama
Shinjuku-Ku, Tokyo, Japan