WHO ICTRP trial
A Phase 3 Single-Arm Study of UGN-102 for Treatment of LG IR NMIBC
CTIS2023-506680-34-00 · EU Clinical Trials Information System · Not Recruiting
Key facts
| Trial ID | CTIS2023-506680-34-00 |
|---|---|
| Public title | A Phase 3 Single-Arm Study of UGN-102 for Treatment of LG IR NMIBC |
| Scientific title | A Phase 3, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-102 as Primary Chemoablative Therapy in Patients with Low Grade (LG) Non-Muscle-Invasive Bladder Cancer (NMIBC) at Intermediate Risk (IR) of Recurrence. - BL011 |
| Primary sponsor | Urogen Pharma Ltd. |
| Registry | EU Clinical Trials Information System |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): No Therapeutic exploratory (Phase II): No Therapeutic confirmatory - (Phase III): Yes Therapeutic use - (Phase IV): No |
| Countries | United States;Serbia;Georgia;Austria;Bulgaria;Estonia;Latvia;Lithuania;Spain;Poland |
| Conditions | Non-Muscle Invasive Bladder Cancer MedDRA version: 20.0Level: PTClassification code: 10005003Term: Bladder cancer Class: 100000004864;Therapeutic area: Diseases [C] - Neoplasms [C04] |
| Interventions | Product Name: UGN-102 (Mitomycin), Product Code:PRD11579824, Pharmaceutical Form: INTRAVESICAL SOLUTION, Other descriptive name: , Strength: |
| Registration date | Mar 10, 2024 |
| Target size | 240 |
| Secondary IDs | NCT05243550;U1111-1312-0682;2021-005948-29 |
| Registry page | euclinicaltrials.eu |
At a glance
- No Results available
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: