CompletedNot Applicable

A Study to Determine Eligibility for CAH-301 (A Study of Gene Therapy for Classic Congenital Adrenal Hyperplasia (CAH) [NCT04783181])

United States65 participantsStarted 2021-07-01

Plain-language summary

This pre-screening study is designed to determine potential eligibility of adults with classic CAH due to 21-hydroxylase deficiency (21-OHD) for participation in the CAH-301 \[NCT04783181\] gene therapy trial with BBP-631.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult male and non-pregnant females with classic CAH (simple virilizing or salt-wasting) due to 21-OHD * Screening/baseline 17-OHP levels \> 5-10 × ULN * Is on a daily regimen of glucocorticoid * Naïve to prior gene therapy or AAV-mediated therapy Exclusion Criteria: * Positive for anti-AAV5 antibodies * History of adrenalectomy and has no significant liver disease

What they're measuring

Number of Participants Potentially Eligible for CAH-301 Study

Timeframe: Up to 5 years

Trial details

NCT IDNCT05101902

SponsorAdrenas Therapeutics Inc

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-08-07

View on ClinicalTrials.gov More Congenital Adrenal Hyperplasia trials