WHO ICTRP trial
An Open Study of the Efficacy and Safety of a new drug in Patients with Bladder…
EUCTR2021-005948-29-BG · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2021-005948-29-BG |
|---|---|
| Public title | An Open Study of the Efficacy and Safety of a new drug in Patients with Bladder Cancer |
| 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 - A Phase 3 Single-Arm Study of UGN-102 for Treatment of LG IR… |
| Primary sponsor | UroGen Pharma Ltd. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| 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 | Greece;Canada;Austria;Latvia;United States;Poland;Georgia;Bulgaria;Serbia;Lithuania;Estonia;Spain |
| Conditions | Non-Muscle Invasive Bladder Cancer MedDRA version: 20.0 Level: PT Classification code 10005003 Term: Bladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area… |
| Interventions | Product Name: UGN-102 (Mitomycin) for Solution Product Code: UGN-102 Pharmaceutical Form: Powder for intravesical solution INN or Proposed INN: MITOMYCIN CAS Number: 50-07-7 Current Sponsor code: UGN-102 Concentration unit: mg milligram(s)… |
| Registration date | Feb 14, 2022 |
| Target size | 220 |
| Secondary IDs | BL011 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: