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Taking people in SpainPhase 4

Long-term follow-up of UGN-103 for recurrent low-grade non-muscle invasive bladder cancer

Follows adults whose bladder cancer responded to UGN-103 in an earlier study.

Key facts

Who runs it
Urogen Pharma Ltd.
Where
Madrid, SpainSee the siteAlso in 4 other countries, 11 sites
Registry title
A Rollover Study to Follow the Long-term Durability of Response to UGN-103 in Participants With Recurrent Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer (LG-IR-NMIBC) From Study BL013
Status
Recruiting
Phase
Phase 4
People taking part
33 people, planned
Started
6 Oct 2026
Expected to end
25 Feb 2032
Type of study
Interventional
Record updated
15 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people who finished study BL013 with a complete response to UGN-103 that is still ongoing. It follows how long the response lasts.

Age
18 years or older
Sex
All sexes can join
Disease stage
Non-muscle invasive bladder cancer, recurrent low-grade intermediate-risk, with an ongoing complete response (CR) at the end of study BL013
Earlier treatment
Must have completed study BL013 and received UGN-103 in that study

Main reasons for not taking part

  • Did not give written informed consent for this rollover study
  • Did not complete study BL013 with an ongoing complete response (CR)

The registry criteria, word for word

Show all 3 criteriaShow less

Who can take part

  • Participant has provided written informed consent for the rollover study
  • Participant completed Study BL013 with an ongoing CR

Who cannot take part

  • Participant has not provided written informed consent for the rollover protocol; 2.Participant did not complete Study BL013 with an ongoing CR

Where in Spain

Also in 4 other countries, 11 sites

  • Hospital Universitario La PazMadrid, SpainTaking people

About the trial

What the trial wants to find out

Collect long-term durability of response data from participants with an ongoing complete response to UGN-103 at the end of Study BL013

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
A Rollover Study to Follow the Long-term Durability of Response to UGN-103 in Participants From Study BL013
Plain-language title
Long-term follow-up of UGN-103 for recurrent low-grade non-muscle invasive bladder cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
15 September 2026