Trials / Active Not Recruiting
Active Not RecruitingNCT05704244
Safety and Efficacy of FE 999326 Administered Intravesically to Japanese Subjects With High-grade, BCG Unresponsive, Non-muscle Invasive Bladder Cancer (NMIBC)
A Phase 3, Open Label Trial to Evaluate the Safety and Efficacy of FE 999326 Administered Intravesically to Japanese Subjects With High-grade, BCG Unresponsive, Non-muscle Invasive Bladder Cancer (NMIBC)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Ferring Pharmaceuticals · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety and efficacy of FE 999326 in Japanese subjects with high-grade, BCG unresponsive NMIBC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FE 999326 | 75 mL FE 999326 (3 x 10\^11 vp/mL) of sterile suspension instilled once every 3 months into the bladder via a urinary catheter |
Timeline
- Start date
- 2022-12-21
- Primary completion
- 2029-11-30
- Completion
- 2029-11-30
- First posted
- 2023-01-30
- Last updated
- 2025-08-28
Locations
24 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT05704244. Inclusion in this directory is not an endorsement.