NORTH-REG Dwell-Time Study

NCT04701151 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: 2020-003112-27
• Study Type: interventional
• Target: 314
• Locations: 3 countries
• Sites: 11

Brief 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

Outcome Measures

Primary Outcomes (1)

• Completion of instillations

  Number of Study Subjects completing all 6 induction instillations and subsequent maintenance installations for 12 months (6 + 3 x 3)

  5 years

Secondary Outcomes (1)

• Recurrence rate

  5 years

Study Arms (2)

Intervention

EXPERIMENTAL

Study Subjects randomized to the interventional arm will be assigned to BCG induction therapy once-weekly for 6 weeks and subsequent 1 year of maintenance (6+3x3) of which dwell-time during the first of the 6 induction instillations is 2 hours. If side effects are registered before the second and all further instillations, Study Subject in the intervention arm will be reduced in dwell-time according to the grading of side effects as given by the study algorithm.

Drug: Bacillus Calmette Guerin

Control

ACTIVE COMPARATOR

The Study Subjects will be treated according to guidelines with BCG instillation therapy once weekly for 6 weeks and subsequent 1 year of maintenance therapy (6+3x3) with 2 hours of dwelltime.

Drug: Bacillus Calmette Guerin

Interventions

Bacillus Calmette Guerin DRUG

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.

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age at the time of signing the Informed Consent Form
• Signed Informed Consent Form
• Patients with NMIBC where BCG therapy including maintenance for 1 year is planned for one of the following histopathological findings:
• Ta high grade without CIS
• CIS with or without previous or concomitant Ta tumors
• T1 with or without CIS
• Is, according to the Investigator's judgement, able to comply with the trial protocol
• Ability to understand the Patient Information Sheet orally and in writing

You may not qualify if:

• Previous BCG instillations within the last 2 years, because of the risk of not having cleared potential previos side effects.
• T1 tumors where re-resection had not been performed
• TUR-B, bladder biopsy or traumatic catheterization within 2 weeks.
• Previous or current MIBC
• Progression defined as progrssion to T1-tumour, T2+\_tumour or cystectomy irrespectievely of indication or development of metastatic urothelial cancer irrespectively of tumour stage
• Contraindications to BCG
• Incontinence
• Bilateral nephrostomy catheters; unilateral nephrostomy catheter is allowed if permanent for the duration of all inistallations with BCG and a normally functioning kidney.
• Need for catheter a demeure at the time of instillation
• Immune Suppressing medication (cancer therapy e.g cytostatic medicinal products, radiation, local and systemic steroids like e.g. prednisolone is permitted)
• Reduced immune response (leukaemia, lymphoma)
• Known allergy or sensitivity to BCG
• HIV infection
• Signs of active tuberculosis
• Any type of previosly radiation therapy involving the bladder.

Sponsors & Collaborators

• Aarhus University Hospital: collaborator
• Herlev Hospital: collaborator
• Odense University Hospital: collaborator
• Aalborg University Hospital: collaborator
• Regional Hospital West Jutland: collaborator
• Rigshospitalet, Denmark: collaborator
• Zealand University Hospital: collaborator
• Landspitali University Hospital: collaborator
• Sahlgrenska University Hospital: collaborator
• Region Örebro County: collaborator
• Karolinska University Hospital: collaborator
• Jørgen Bjerggaard Jensen: lead

Study Sites (11)

Aarhus University Hospital

Aarhus, Aarhus N, 8200, Denmark

Location

Department of Urology, Aalborg University Hospital

Aalborg, 9100, Denmark

Location

Department of Urology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Herlev Hospital

Herlev, Denmark

Location

Regional Hospital Gødstrup

Herning, 7400, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Zealand University Hospital

Roskilde, 4000, Denmark

Location

Landspitali University Hospital

Reykjavik, 101, Iceland

Location

PO Sahlgrenska Universitetssjukhuset

Gothenburg, sw 413 45, Sweden

Location

Örebro University Hospital

Örebro, 701 85, Sweden

Location

Karolinska University Hospital

Stockholm, 141-86, Sweden

Location

MeSH Terms

Interventions

BCG Vaccine

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Consultant, MD, DMSc Department of Clinical Medicine, Aarhus University

Model Details: multi-center, multi-national, two-armed, randomized, open-label, investigator-initiated clinical controlled - phase IV trial.

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 8, 2021
• Study Start: February 3, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (7); IC (1); SE (3)