2024-514628-17-00CompletedPhase 1/2
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
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 9 Jan 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 76 (actual)
- First submitted
- 19 Nov 2024
- Start date
- 21 May 2018
- Lead sponsor
- Hamlet BioPharma AB
- Diseases
- Bladder cancer
- EU CT number
- 2024-514628-17-00
- EudraCT number
- 2016-004269-14
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 76
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Participants with any other cancer diagnosis within the last 5 years (except of skin basaliomas)
- Acute urinary tract infection
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fakultni nemocnice v Motole | Prague | Czechia | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.