ADventure: Investigational Gene Therapy for Adult Classic CAH
ABOUT THE ADVENTURE GENE THERAPY TRIAL FOR ADULT CAH
Adrenas is the only company currently working to develop a gene therapy that may enable people living with congenital adrenal hyperplasia (CAH) to produce the hormones that the body needs to function properly.
The specific goal of the Adrenas ADventure trial is to provide a safe and effective gene therapy treatment that may correct hormone imbalances in adults living with classic CAH due to 21-hydroxylase deficiency. The trial will evaluate the safety, tolerability and optimal dose range of the investigational gene therapy. The ADventure trial is being conducted in the United States.
You may be eligible for the ADventure Gene Therapy Trial for Adult Classic CAH if:
You are 18 years of age or older
You have a diagnosis of classic CAH (simple-virilizing or salt-wasting)
Other eligibility criteria apply, and you may complete a Pre-screening Study to see whether you may be able to take part.
For more information about ADventure including additional eligibility criteria, please visit https://clinicaltrials.gov/ct2/show/NCT04783181.
During the clinical trial, the Adrenas investigational gene therapy will be administered in a single intravenous
dose.
There is no cost for taking part in the ADventure Gene Therapy Trial for CAH, or during the Pre-screening Study or Long-term Follow-up as described below. Travel and trial-related expenses will be paid for by Adrenas.
Click “NEXT” to answer the first set of pre-screening questions
WHAT TO EXPECT?
A pre-screening study has been established to help identify adults living with classic CAH who may be eligible to enroll in the ADventure gene therapy trial. After signing consent for this pre-screening study, participation will include medical record review, remote study visits, laboratory tests and home visits. If potential eligibility for the ADventure gene therapy trial is confirmed in this pre-screening study, participants will be periodically re-evaluated for continued interest and eligibility for possible referral to a clinical site for enrollment in the ADventure trial.
The treatment trial includes up to 6 weeks of additional screening. Eligible participants will then receive the investigational gene therapy in a one-time intravenous dose. Initial participation in the ADventure trial will be approximately 1 year after receiving the investigational gene therapy, with long term follow-up (see below).
Upon completion of the 1-year ADventure gene therapy trial, study participants who have received the investigational treatment will have an additional follow-up period of 4 years, as is required by regulatory agencies. During this time, participants will have additional remote and clinic study visits. Study visits will be less frequent in the long-term follow-up.
Click “NEXT” to answer the first set of pre-screening questions
If you’re not ready to take part in this study but you would still like to follow its progress, click here to sign up for updates.
Initial Pre-screening for the ADventure Gene Therapy Trial
Please note:
If your answers show that you are eligible to move forward, a member of the ADvance-CAH team will contact you to follow-up.
By completing this form, you are not obligated to participate in the pre-screening or ADventure Trial. You may opt out at any time and do not have to provide a reason.
This is a secure site and all information will be stored and processed in a confidential way, in accordance with the Health Insurance Portability and Accountability Act of 1996, commonly known as HIPAA. We will ask for your consent before sharing any personal information with the clinical trial sponsor (Adrenas) and its screening partners.
NEED HELP?
For questions related to the Adrenas clinical program, please email: clinicaltrials@adrenastx.com
For Frequently Asked Questions about ADventure and the ADvance-CAH program click here
©2024 Adrenas Therapeutics, Inc.
All Rights Reserved
©2024 Adrenas Therapeutics, Inc.
All Rights Reserved
