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A Phase I/II Randomized Study Evaluating if the study drug Alpha1H is effective and safe in comparison to placebo in adult patients with bladder cancer before planned surgery to remove tumour
EU CTIS ID: 2024-514628-17-00
What this study is testing
The main objective is to evaluate the safety and assess the efficacy of intravesical instillation of Alpha1H in subjects with non-muscle invasive bladder cancer
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed and dated informed consent
- Patient with non-muscle invasive papillary bladder cancer (NMIBC) based on cystoscopy appearance, on the waiting list for TURB
- Male and female subjects, 18 years or older
- Negative pregnancy test in women of childbearing potential
- Appropriate methods of contraception in women of childbearing potential during study
- Patients should be able to keep the content of the bladder for at least one hour
You likely can't join if
- Patient with a previous history of muscle invasive bladder cancer
- Previously enrolled in this trial
- Patient with a history of NMIBC with an interval shorter than 6 months after previous TURB
- Previous intravesical BCG immunotherapy in the last 12 months
- Previous intravesical chemotherapy in the last 12 months
- Participants with any other cancer diagnosis within the last 5 years (except of skin basaliomas)
See the full eligibility criteria
- Signed and dated informed consent
- Patient with non-muscle invasive papillary bladder cancer (NMIBC) based on cystoscopy appearance, on the waiting list for TURB
- Male and female subjects, 18 years or older
- Negative pregnancy test in women of childbearing potential
- Appropriate methods of contraception in women of childbearing potential during study
- Patients should be able to keep the content of the bladder for at least one hour
- Patient with a previous history of muscle invasive bladder cancer
- Previously enrolled in this trial
- Patient with a history of NMIBC with an interval shorter than 6 months after previous TURB
- Previous intravesical BCG immunotherapy in the last 12 months
- Previous intravesical chemotherapy in the last 12 months
- Participants with any other cancer diagnosis within the last 5 years (except of skin basaliomas)
- Acute urinary tract infection
- Participants with prior radiotherapy or systemic chemotherapy
- Participants receiving any other investigational agent or non-marketed product one month prior to Visit 1 and during the trial
- Any concurrent illness that may render a participant ineligible or limit compliance with study requirements
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.