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NORTH-REG Dwell-Time Study

NCT04701151 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2026-03-03

No results posted yet for this study

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.

Conditions

  • Side Effect of Drug

Interventions

DRUG

Bacillus Calmette Guerin

The same dose of the drug will be given in both arms but the dwell-time will be adjusted for the subjects in the intervention arm according to the grading of side effects given by the study algorithm.

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Herlev Hospital

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Aalborg University Hospital

    collaborator OTHER

  • Regional Hospital West Jutland

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Zealand University Hospital

    collaborator OTHER

  • Landspitali University Hospital

    collaborator OTHER

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Region Örebro County

    collaborator OTHER

  • Karolinska University Hospital

    collaborator OTHER

  • Jørgen Bjerggaard Jensen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-03
Primary Completion
2026-12-31
Completion
2030-12-31

Countries

  • Denmark
  • Iceland
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04701151 on ClinicalTrials.gov