Congenital Adrenal Hyperplasia study: Crinecerfont
Official title Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Crinecerfont in Participants With Classic Congenital Adrenal Hyperplasia (CAH) Who Are Less Than 4 Years Old
ClinicalTrials.gov ID: NCT07536269
What this study is testing
What is Crinecerfont?
Crinecerfont is an investigational oral solution being studied for congenital adrenal hyperplasia in children.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to determine how safe and well tolerated crinecerfont is in young children with CAH.
- Who it's for
- Children aged 3 months to less than 4 years who have congenital adrenal hyperplasia.
- What's involved
- Participants will receive the study medication and attend scheduled medical visits and tests to monitor safety.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 47
You may be able to join if
- Have a medically confirmed diagnosis of classic CAH (salt wasting or simple virilizing) due to 21-hydroxylase deficiency (21-OHD)
- Have received at least 3 months of hydrocortisone treatment before Day 1, with a stable dose for at least 4 weeks before screening.
- Have a body weight of at least 4.5 kilograms (kg) at screening.
- Have a newborn screen that is otherwise normal except for elevated 17-OHP or any other abnormality on newborn screen that was cleared upon evaluation...
You likely can't join if
- Have a known or suspected diagnosis of any of the other forms of classic CAH.
- Have any condition besides CAH that requires chronic daily therapy with orally administered steroids.
- Have any other clinically significant medical condition or chronic disease. Note: Other protocol-defined inclusion and exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
- Aurora, Colorado, United States
- Hartford, Connecticut, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 months to 47 months. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States; Aurora, Colorado, United States; Hartford, Connecticut, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Indianapolis, Indiana, United States and 5 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.