ADSTILADRIN Early Utilization and Outcomes in the Real World Setting in the United States

Study Identifier:
431
CT.gov Identifier:
NCT06026332
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Terminated/Withdrawn

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Study Summary

To collect data on the early use of ADSTILADRIN in the US. Data will be collected from participants, caregivers and prescribing physicians in a real-world setting.

To evaluate the effectiveness, overall experiences, patterns of use, and safety in patients treated with nadofaragene firadenovec in a US real-world setting.

Patient and caregiver experiences will be assessed using the respective EuroQol 5 Dimension 5 Level questionnaire and Work Productivity and Activity Impairment questionnaire, adapted for caregiving. Patients and caregivers will be surveyed before all nadofaragene firadenovec administrations. Physicians will be surveyed 1, 12, and 24 months after first patient first instillation. All AE data will be collected starting from index date. The estimated follow-up period is 24 months, until study discontinuation, or withdrawal.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Bladder
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    IV
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Adults ≥18 years with prescribed and scheduled treatment with nadofaragene firadenovec per physician discretion or those who received their first instillation of nadofaragene firadenovec per physician discretion after September 5, 2023, but before site activation are eligible to enroll.
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  • Drug: Patients receive ADSTILADRIN in the routine care setting, including re-induction with a second quarterly dose in patients without a complete response to the initial single dose
  • Drug: ASCO 2025:
  • Drug: Patients aged 18 years or older who are being treated with ADSTILADRIN in a clinical setting and had not previously received this therapy in a clinical trial.
  • Drug: Participants in ABLE-41 will be followed for 24 months, or until study discontinuation or withdrawal.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Terminated/Withdrawn

    Requirements information
    Inclusion criteria
    • - Prescribed and scheduled treatment with ADSTILADRIN per physician discretion or
    • received the first instillation of ADSTILADRIN per physician discretion after 5
    • September 2023 but prior to site activation
    • - Signed and dated ICF.
    • - Age 18 years or older at day ICF is signed.
    • Eligible patients include those who were prescribed and scheduled to receive treatment, per their physician’s discretion, or patients who received their first instillation (per physician discretion) after September 5, 2023, but before the site was activated in the trial.
    Exclusion criteria
    • - Currently enrolled in a clinical trial.
    • - Participants who have previously been treated with ADSTILADRIN in the context of a
    • clinical trial
    • - Participant is pregnant or breastfeeding.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Carolinas
    Myrtle Beach, SC, United States, 29572
    Investigator
    Neal Shore
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Bladder