WHO ICTRP trial
Standard number and dose intravesical instillation therapy with BCG versus…
EUCTR2010-019181-91-DE · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2010-019181-91-DE |
|---|---|
| Public title | Standard number and dose intravesical instillation therapy with BCG versus Reduced number and standard dose intravesical instillation therapy with BCG in patients with high grade non-muscle invasive urinary bladder carcinoma. |
| Scientific title | Treatment of High Grade Non-Muscle Invasive Urothelial Carcinoma of the Bladder by Standard Number and Dose of Intravesical BCG Instillations Versus Reduced Number of Intravesical Instillations with Standard Dose of BCG. A European Association of Urology Research Foundation Randomised Phase III… |
| Primary sponsor | EAU Foundation for Urological Research |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | France;Spain;Belgium;Germany |
| Conditions | Non muscle invasive bladder cancer after transurethral resection of the Bladder Tumor (TURT). MedDRA version: 20.0 Level: PT Classification code 10005003 Term: Bladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and… |
| Interventions | Trade Name: BCG -medac Product Name: BCG Vaccine for intravesical instillation Pharmaceutical Form: Intravesical solution Trade Name: The IMP used for the standard arm is BCG vaccine which is payed by the insurances because it is the… |
| Registration date | May 21, 2013 |
| Target size | 824 |
| Secondary IDs | EAURF2008-01;AB37/10;NTR4011;DRKS00005651 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: