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ACTIVE NOT RECRUITING Phase 1

A Study of Gene Therapy for Classic Congenital Adrenal Hyperplasia (CAH)

NCT04783181 · View on ClinicalTrials.gov ↗

Study Summary

This study is designed to evaluate the safety, tolerability, and efficacy of AAV5 based BBP-631 in adult participants diagnosed with classic congenital adrenal hyperplasia.

Interventions

  • BIOLOGICAL AAV BBP-631

Study Locations (5)

Illinois

  • Ann and Robert H. Lurie Children's Hospital of Chicago — Chicago

Maryland

  • National Institutes of Health Clinical Center — Bethesda

Minnesota

  • University of Minnesota — Minneapolis

North Carolina

  • Lucas Research, Inc. — Morehead City

Pennsylvania

  • Children's Hospital of Philadelphia — Philadelphia

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2021-07-01
Est. Completion 2029-02
Phase Phase 1

Sponsor

Adrenas Therapeutics

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04783181

The ClinicalTrials.gov registry entry for NCT04783181 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Adrenas Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Congenital Adrenal Hyperplasia appearing as the primary indexed condition, and to 1 intervention — of which AAV BBP-631 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04783181 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Illinois, Maryland, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04783181 about?

NCT04783181 is a clinical study titled "A Study of Gene Therapy for Classic Congenital Adrenal Hyperplasia (CAH)". This study is designed to evaluate the safety, tolerability, and efficacy of AAV5 based BBP-631 in adult participants diagnosed with classic congenital adrenal hyperplasia.

What is the current status of trial NCT04783181?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2021-07-01. Estimated completion is 2029-02.

What conditions does trial NCT04783181 study?

This clinical trial studies the following conditions: Congenital Adrenal Hyperplasia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04783181?

The interventions under investigation include: AAV BBP-631 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04783181?

This trial is sponsored by Adrenas Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04783181 being conducted?

This trial has 5 study locations across Illinois, Maryland, Minnesota, North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial