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
Key facts
- Where
- Prague, CsehországSee the site
- Phase
- 1/2. fázis
Where in Csehország
- Fakultni nemocnice v MotolePrague, CsehországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hamlet BioPharma AB
- Trial code
- EU 2024-514628-17-00
- Record updated
- 2025. január 9.
- Original description
The main objective is to evaluate the safety and assess the efficacy of intravesical instillation of Alpha1H in subjects with non-muscle invasive bladder cancerRead full original descriptionShow less
A Randomized Placebo controlled Phase I/II Study Evaluating the Safety and Efficacy of Alpha1H in adult patients with non-muscle invasive bladder cancer awaiting transurethral surgery
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
Inclusion: 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.
Exclusion: 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 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; Participants with any other cancer diagnosis within the last 5 years (except of skin basaliomas); Acute urinary tract infection.