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Terminated Phase 1 Interventional

Gene Transfer Clinical Study in Crigler-Najjar Syndrome

ClinicalTrials.gov ID: NCT03223194

Public ClinicalTrials.gov record NCT03223194. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 4:01 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

VALENS: A Phase 1/2, Randomized, Open-Label, Ascending-Dose, Delayed-Treatment Concurrent Control Clinical Study to Evaluate the Safety and Preliminary Efficacy of AT342, an AAV8-Delivered Gene Transfer Therapy in Crigler-Najjar Syndrome Subjects Aged 1 Year and Older

Study identification

NCT ID
NCT03223194
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 1
Lead sponsor
Audentes Therapeutics
Industry
Enrollment
1 participant

Conditions and interventions

Interventions

  • AT342 Genetic

Genetic

Eligibility (public fields only)

Age range
1 Year and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 7, 2017
Primary completion
Feb 10, 2021
Completion
Feb 10, 2021
Last update posted
May 17, 2022

2017 – 2021

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
Children's Hospital at Montefiore The Bronx New York 10467
Clinic for Special Children Strasburg Pennsylvania 17579

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03223194, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 17, 2022 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03223194 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →