Side Effect of DrugPhase 4NCT04701151
NORTH-REG Dwell-Time Study
A Phase 4 study testing Bacillus Calmette Guerin in people with Side Effect of Drug, run by Jørgen Bjerggaard Jensen at 11 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Side Effect of Drug
- What is being tested?
- Bacillus Calmette Guerin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 3 Feb 2021to Dec 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
Show all 24Show fewer
- 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.
- Concomitant invasive cancer within 5 years other than non-melanoma skin cancer and protate cancer without metastasis
- Current urinary tract infection
- Patient with visible hematuria
- Current alcohol and/or drug abuse
- Has a mental or legal incapacitation or another condition which impair the subject's ability to participate
- Has participated in another interventional clinical study and treatment with another investigational product 30 days prior to randomization
- For women study subjects: Pregnancy or breastfeeding
- For women Study subjects of childbearing potential: unless they are using highly effective methods of contraception from the first BCG instillations until 14 days after last dose of BCG treatment, which are defined as total abstinence, female sterilization, use of oral methods of contraception or placement of an intrauterine contraception devices.
- For male Study Subjects: unless they are using highly effective methods of contraception from the first BCG instillation until for 14 days after last dose of BCG treatment, which is defined as total abstinence or use of condoms.
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
Denmark7 sites
Department of Urology, Aalborg University Hospital
Aalborg, 9100
Aarhus University Hospital
Aarhus, Aarhus N, 8200
Department of Urology, Rigshospitalet
Copenhagen, 2100
Herlev Hospital
Herlev
Regional Hospital Gødstrup
Herning, 7400
Odense University Hospital
Odense, 5000
Zealand University Hospital
Roskilde, 4000
Sweden3 sites
PO Sahlgrenska Universitetssjukhuset
Gothenburg, sw 413 45
Örebro University Hospital
Örebro, 701 85
Karolinska University Hospital
Stockholm, 141-86
About this study
Official title: Nordic Urothelial Cancer Research Group Study on Reduced BCG Dwell-Time in High Risk NMIBC
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.
Read the detailed description
Approximately 8,000 patients are diagnosed with bladder cancer (BC) in the Nordic countries every year. The majority of BC patients are diagnosed with non-muscle invasive bladder cancer (NMIBC). The majority of NMIBC are treated with Bacillus Calmette-Guérin vaccine (BCG) as adjuvant treatment but for carcinoma in situ it is the primary treatment. BCG is known to give a lot of side effects both local and systemic, the severity of these can lead to premature termination of the treatment.
The object of this PhD project is to investigate if reduced dwell time, the time the BCG is in the bladder, will decrease the severity of side effects due to BCG instillations.
This will be investigated in a Nordic setting and the project will be done as a two-armed randomized clinical trial.
By decreasing the severity of side effects, we hypothesize the number of patients completing all planned instillations will increase and thereby decrease the risk of the BC evolving into a more aggressive type.
- Conditions
- Side Effect of Drug
- Being tested
- Bacillus Calmette Guerin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacillus Calmette GuerinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Bacillus Calmette Guerin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of instillations
Number of Study Subjects completing all 6 induction instillations and subsequent maintenance installations for 12 months (6 + 3 x 3)
Measured: 5 years
Secondary outcomes (1)
Recurrence rate
Recurrence rate within 24 months in Study Subjects with initial complete response
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start3 Feb 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Side Effect of DrugStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multi-center, multi-national, two-armed, randomized, open-label, investigator-initiated clinical controlled - phase IV trial.
- Masking
- None (open label)
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jørgen Bjerggaard Jensen
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Herlev Hospital, Odense University Hospital, Aalborg University Hospital, Regional Hospital West Jutland, Copenhagen University Hospital, Rigshospitalet, Zealand University Hospital, Landspitali University Hospital, Sahlgrenska University Hospital, Region Örebro County, Karolinska University Hospital
- Responsible party
- Sponsor-investigator, Jørgen Bjerggaard Jensen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701151
- Sponsor's protocol ID
- 2020-003112-27
- Status last verified
- Mar 2026
- First submitted
- 6 Jan 2021
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nordic Urothelial Cancer Research Group Study on Reduced BCG Dwell-Time in High Risk NMIBC
- ClinicalTrials.gov ID
- NCT04701151
- Acronym / sponsor ID
- 2020-003112-27
- Conditions
- Side Effect of Drug
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- Jørgen Bjerggaard JensenUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Herlev Hospital, Odense University Hospital, Aalborg University Hospital, Regional Hospital West Jutland, Copenhagen University Hospital, Rigshospitalet, Zealand University Hospital, Landspitali University Hospital, Sahlgrenska University Hospital, Region Örebro County, Karolinska University Hospital
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately 8,000 patients are diagnosed with bladder cancer (BC) in the Nordic countries every year. The majority of BC patients are diagnosed with non-muscle invasive bladder cancer (NMIBC). The majority of NMIBC are treated with Bacillus Calmette-Guérin vaccine (BCG) as adjuvant treatment but for carcinoma in situ it is the primary treatment. BCG is known to give a lot of side effects both local and systemic, the severity of these can lead to premature termination of the treatment.
The object of this PhD project is to investigate if reduced dwell time, the time the BCG is in the bladder, will decrease the severity of side effects due to BCG instillations.
This will be investigated in a Nordic setting and the project will be done as a two-armed randomized clinical trial.
By decreasing the severity of side effects, we hypothesize the number of patients completing all planned instillations will increase and thereby decrease the risk of the BC evolving into a more aggressive type.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- multi-center, multi-national, two-armed, randomized, open-label, investigator-initiated clinical controlled - phase IV trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Bacillus Calmette GuerinStudy 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. |
| Control | Active comparator | Drug: Bacillus Calmette GuerinThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacillus Calmette GuerinThe 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. | Drug | Control, Intervention |
Primary outcome
Completion of instillations
Time frame: 5 years
Number of Study Subjects completing all 6 induction instillations and subsequent maintenance installations for 12 months (6 + 3 x 3)
1 secondary outcome
Recurrence rate
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Side Effect of Drug
Not yet recruitingPhase 2
The Impact of Using Nicorandil for the Prevention of Doxorubicin-Induced Cardiotoxicity
Doxorubicin Induced Cardiotoxicity, Doxorubicin Induced Cardiomyopathy
Active, not recruiting
Comparative Study of the Quality of Life of Patients Suffering From OTOTOXICITY Due to Chemotherapy Based on Platinum Salts Fitted With a Hearing Aid Compared to Those Not Fitted.
Cancer, Ototoxicity, Drug-Induced
RecruitingObservational study
Post-market Safety Study of LUMISIGHT
Hypersensitivity Reactions
RecruitingObservational study
Heart Failure in Women: Epidemiological and Prognostic Insights
Heart Failure
Active, not recruitingPhase 2
Autologous Serum Obtained by a Closed-Circuit Collection Device
GVHD, Meibomian Gland Dysfunction (Disorder)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bacillus Calmette Guerin in people with Side Effect of Drug, run by Jørgen Bjerggaard Jensen at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Denmark, Sweden, Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of instillations (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.