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Phase IV post-authorization safety clinical trial to investigate the long-term safety of lutetium (177Lu) vipivotide tetraxetan in adult participants with prostate cancer.
THE OBJECTIVE OF THE STUDY IS TO INVESTIGATE THE LONG-TERM EFFECTS OF TREATMENT WITH AAA617 IN PATIENTS WHO RECEIVED IT FOR THEIR PROSTATE CANCER. THE STUDY PHYSICIAN WILL FOCUS ON KNOWN OR POTENTIAL LONG-TERM SIDE EFFECTS. SAFETY ASSESSMENTS WILL BE PERFORMED FOR UP TO 10 YEARS, STARTING FROM THE FIRST DOSE OF AAA617 IN THE PREVIOUS TREATMENT STUDY.
Technical Summary
- PHASE IV POST-AUTHORIZATION SAFETY STUDY TO INVESTIGATE THE LONG-TERM SAFETY OF LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN IN ADULT PARTICIPANTS WITH PROSTATE CANCER.
- Code EudraCT: 2023-503208-94-00
- Protocol number: CAAA617A12402
- Promoter: Novartis Pharma AG
- Molecule/Drug: 177Lu
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* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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