Therapeutic Instillation of Mistletoe
NCT02106572 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 174
Last updated 2026-05-22
Summary
The aim of this phase III study is to assess the efficacy of abnobaVISCUM® 900 compared with Mitomycin C (MMC) monotherapy in patients with superficial bladder carcinoma by evaluation of the time to tumor recurrence. Secondary objective is to evaluate the safety of abnobaVISCUM® 900, in particular, to compare the toxicity of the two treatments. Another secondary objective is the treatment efficacy as measured by calculated prognosis for recurrence and progression after 1 year, the tumor grading in case of a recurrence and by measurement of Quality of Life.
Conditions
- Superficial Bladder Cancer
Interventions
- DRUG
-
abnobaVISCUM 900
intravesical instillation of abnobaVISCUM 900 13 times during treatment period
- DRUG
-
Mitomycin C
intravesical instillation of Mitomycin C 10 times during treatment period
Sponsors & Collaborators
-
Abnoba Gmbh
lead INDUSTRY
Principal Investigators
-
Jochen Hess, Prof. Dr. · Chief Medical Officer of the Urological Clinic of the University Hospital Essen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-04-30
- Primary Completion
- 2026-03-24
- Completion
- 2026-04-24
Countries
- Egypt
- Germany
Study Locations
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