#1 Clinical Trials Search in Europe

Alpha1H

Clinical trials are investigating Alpha1H in adults with non-muscle invasive bladder cancer who are waiting for transurethral surgery. These studies look at safety and early signs of benefit, including tumor response before surgery.

Table of Contents

Trial overview

The available trial studied Alpha1H in adult patients with non-muscle invasive bladder cancer who were waiting for transurethral surgery to remove the tumor.[1] The study was described as a Phase I/II randomized study in the title and as Phase 1 in the trial record, which means it was an early clinical trial focused on safety and first signs of benefit.[1] The trial status was Completed, and the enrollment was 76 participants.[1]

Who could join the study

The target population was adults with bladder cancer that had not grown into the muscle layer of the bladder wall.[1] The study focused on people who were already scheduled for surgery through the urethra, so the treatment was tested before the planned tumor removal.[1]

This type of study is important because it looks at patients at a specific point in care: before surgery, when researchers can measure the tumor directly and compare changes over time.[1]

What was studied

The study compared Alpha1H with a placebo product for Alpha1H.[1] A placebo is a look-alike treatment used for comparison, so researchers can better judge whether the study drug has an effect.[1]

Alpha1H was given by intravesical use, which means it was placed directly into the bladder.[1] The main aim was to evaluate whether this approach was safe and whether it could help change the tumor before surgery.[1]

Main endpoints and safety checks

The main safety endpoint was adverse events, meaning any medical problems or unwanted effects seen during the study and for 30 days after the last treatment or placebo dose.[1] The trial also checked vital signs, ECG, and laboratory parameters to monitor general safety.[1]

To look for tumor response, the study measured cell shedding in urine, which was used as a biomarker, meaning a measurable sign that may show how the tumor is reacting to treatment.[1] Researchers also used cystoscopy imaging to see the tumor in the bladder and examined the removed tissue with histopathology after surgery.[1]

The trial description says the researchers expected Alpha1H to trigger tumor cell shedding into urine and to cause changes in tumor size and shape, based on earlier studies and a murine bladder cancer model.[1] In this study report, those effects were part of what the researchers planned to look for, not proven results.[1]

How the trial was designed

This was an interventional trial, which means the researchers gave a study treatment and then measured the results.[1] It was also randomized, so participants were assigned to a study group by chance rather than by choice.[1]

Randomized studies help compare treatments more fairly because they reduce bias, which is when outside factors affect the results.[1] In this trial, the comparison was between Alpha1H and placebo before the planned operation.[1]

Trial ID Phase Condition studied Status Enrollment
2024-514628-17-00 Phase 1 Non-muscle invasive bladder cancer awaiting transurethral surgery Completed 76

FAQ

  • What is being studied in Alpha1H trials? The trials study whether Alpha1H is safe and whether it may help reduce or change bladder tumors before surgery. They also compare Alpha1H with placebo.
  • Who can take part in these trials? The trial data describe adult patients with non-muscle invasive bladder cancer who are awaiting transurethral surgery to remove the tumor. Participation depends on the study rules.
  • What phase is the Alpha1H study? The trial is listed as Phase 1 and Phase I/II in the title, showing that it is an early-stage study. Early-phase trials mainly focus on safety and first signs of effect.
  • What outcomes are measured? The study measures adverse events, vital signs, ECG, laboratory values, cell shedding in urine, cystoscopy imaging, and histopathology of the removed tumor. These help show safety and tumor response.
  • Is Alpha1H compared with another treatment? Yes. The study compares Alpha1H with a placebo product. A placebo looks like the study treatment but does not contain the active study drug.

Ongoing Clinical Trials on Alpha1H

  • Study on the Safety and Effectiveness of Alpha1H for Adults with Non-Muscle Invasive Bladder Cancer Awaiting Tumor Removal Surgery

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Czechia

Glossary

  • Bladder cancer: A cancer that starts in the bladder, the organ that stores urine.
  • Non-muscle invasive: Cancer that has not grown into the muscle layer of the bladder wall.
  • Transurethral surgery: Surgery done through the urethra, the tube that carries urine out of the body, to remove a bladder tumor.
  • Placebo: A look-alike treatment used for comparison in a trial. It does not contain the active study drug.
  • Phase 1: An early trial phase that mainly checks safety and how the body responds to a treatment.
  • Intravesical: Given directly into the bladder.
  • Adverse events: Medical problems or unwanted effects that happen during a study, whether or not they are caused by the treatment.
  • ECG: A heart test that records the electrical activity of the heart.
  • Laboratory parameters: Blood or urine test results used to check health and safety.
  • Cystoscopy: A procedure that uses a thin camera to look inside the bladder.
  • Histopathology: A lab study of tissue under a microscope to look for cancer changes.

References

  1. https://clinicaltrials.gov/study/2024-514628-17-00