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A First-in-Human Study of alpha1H in Patients With Non-muscle Invasive Bladder Cancer

NCT03560479 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2020-08-19

No results posted yet for this study

Summary

This study evaluates the tolerability and preliminary anti-tumour effect of alpha1H in adults with non-muscle invasive bladder cancer, who are awaiting transurethral surgery.

In the main, blinded part of the study, one group of subjects will receive treatment with alpha1H and the other half will receive placebo. In a second, dose-escalation part of the study, a third and fourth group of subjects will receive increased doses of alpha1H.

The treatment is given on 6 occasions during a period of 22 days. The study duration is 8 - 12 weeks including scheduled follow-up and up to 27 months when an optional 24-months non-interventional follow-up period is included.

Conditions

Interventions

DRUG

alpha1H, 7.4 mg/mL

Intravesical instillations on 6 occasions during 22 days (Days 1, 3, 5, 8, 15 and 22)

OTHER

placebo

Intravesical instillations on 6 occasions during 22 days (Days 1, 3, 5, 8, 15 and 22)

DRUG

alpha1H, 37 mg/mL

Intravesical instillations on 6 occasions during 22 days (Days 1, 3, 5, 8, 15 and 22)

DRUG

alpha1H, 74 mg/mL

Intravesical instillations on 6 occasions during 22 days (Days 1, 3, 5, 8, 15 and 22)

Sponsors & Collaborators

  • Hamlet Pharma AB

    lead INDUSTRY

Principal Investigators

  • Marek Babjuk, MD, Prof. · Motol University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-21
Primary Completion
2021-12-31
Completion
2023-12-31

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03560479 on ClinicalTrials.gov