drugset / Trial / NCT04701151
NORTH-REG Dwell-Time Study
Phase 4
Active not recruiting
314 enrolled
Jørgen Bjerggaard Jensen
Aalborg University Hospital · collabAarhus University Hospital · collabHerlev Hospital · collabKarolinska University Hospital · collabLandspitali University Hospital · collabOdense University Hospital · collabRegion Örebro County · collabRegional Hospital West Jutland · collabRigshospitalet, Denmark · collabSahlgrenska University Hospital · collabZealand University Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Previous studies show that the majority NMIBC patients experience side effects to BCG and therefore terminate the instillations before completing all planned instillations. This will increase their risk of recurrence and potential cystectomy. The purpose of this study is to investigate if NMIBC patients who experience severe side effects to BCG instillations will experience fewer or less severe side effects if reducing dwell-time of BCG instillations. The study will include patients from Denmark, Iceland, Norway and Sweden.
Timeline
- Start
- 2021-02-03
- Primary completion
- 2026-12
- Completion
- 2030-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bacillus Calmette-Guérin | Vaccine | — | Other |
Indications
No indication recorded.