deltatrials
Terminated PHASE1 INTERVENTIONAL 4-arm NCT03223194

Gene Transfer Clinical Study in Crigler-Najjar Syndrome (VALENS)

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

Sponsor: Audentes Therapeutics

Conditions Crigler-Najjar Syndrome
Interventions AT342
Updated 12 times since 2017 Last updated: May 12, 2022 Started: Sep 8, 2017 Primary completion: Feb 11, 2021 Completion: Feb 11, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Sponsor Decision

This PHASE1 trial investigates Crigler-Najjar Syndrome and is currently terminated or withdrawn. Audentes Therapeutics leads this study, which shows 12 recorded versions since 2017 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Aug 2017 – ~Oct 2017 · 2 months · monthly snapshotNot Yet Recruiting~Oct 2017 – ~Mar 2018 · 5 months · monthly snapshotRecruiting~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshotRecruiting~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshotRecruiting~Sep 2018 – ~Jul 2019 · 10 months · monthly snapshotRecruiting~Jul 2019 – ~Jan 2021 · 18 months · monthly snapshotSuspended~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshotSuspended~Mar 2021 – ~Jun 2022 · 15 months · monthly snapshotTerminated~Jun 2022 – ~Jul 2024 · 25 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotTerminated~Sep 2025 – present · 10 months · monthly snapshotTerminated

Change History

12 versions recorded

  1. Sep 2025 — Present [monthly]

    Terminated PHASE1

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE1

  4. Jun 2022 — Jul 2024 [monthly]

    Terminated PHASE1

    Phase: PHASE1_PHASE2 → PHASE1

  5. Mar 2021 — Jun 2022 [monthly]

    Terminated PHASE1_PHASE2

    Status: Suspended → Terminated

▶ Show 7 earlier versions

  1. Jan 2021 — Mar 2021 [monthly]

    Suspended PHASE1_PHASE2

  2. Jul 2019 — Jan 2021 [monthly]

    Suspended PHASE1_PHASE2

    Status: Recruiting → Suspended

  3. Sep 2018 — Jul 2019 [monthly]

    Recruiting PHASE1_PHASE2

  4. Jun 2018 — Sep 2018 [monthly]

    Recruiting PHASE1_PHASE2

  5. Mar 2018 — Jun 2018 [monthly]

    Recruiting PHASE1_PHASE2

  6. Oct 2017 — Mar 2018 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Not Yet Recruiting → Recruiting

  7. Aug 2017 — Oct 2017 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Audentes Therapeutics
Data source: Audentes Therapeutics

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations