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Clinical trial

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

ID
Name
000431
Description
Multi-center, prospective non-interventional study 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.
Trial arms
Trial start
2023-09-15
Estimated PCD
2025-12-31
Trial end
2025-12-31
Status
Recruiting
Treatment
ADSTILADRIN
Non-interventional
Arms:
ADSTILADRIN
Other names:
Nadofaragene Firadenovec
Size
800
Primary endpoint
Whether or not a patient with CIS (with or without concomitant high-grade Ta or T1 papillary disease) achieves Complete Response (CR) at first evaluation from first ADSTILADRIN instillation
3 months
Whether or not a patient with CIS (with or without concomitant high-grade Ta or T1 papillary disease) achieves CR at any time within 1 year from first ADSTILADRIN instillation
1 year
Eligibility criteria
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. 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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 800, 'type': 'ESTIMATED'}}
Updated at
2024-05-30

1 organization

1 product

1 indication

Organization
Ferring Pharmaceuticals
Product
ADSTILADRIN
Indication
Bladder Cancer