ZPRÁVA O PRŮBĚHU KLINICKÉHO HODNOCENÍ PROOF (4.6.2021-3.6.2022)
| Title in English | REPORT ON THE PROGRESS OF THE CLINICAL EVALUATION OF PROOF (4.6.2021-3.6.2022) |
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| Year of publication | 2022 |
| MU Faculty or unit | |
| Web | PROOF |
| Description | EudraCT number: 2017-001355-31 PROOF: Penumbral Rescue by Normobaric Administration O = O in Patients with Ischemic Stroke and Target Mischmatch ProFile: Phase II, Proof-of-Concept (PROOF: "Penumbral Rescue by Normobaric O = O Administration in Patients with Ischemic Stroke and Target Mismatch ProFile: A Phase II Proof-of-Concept Trial) The study is conducted in addition to the Czech Republic in Germany, Belgium, Finland, France, Spain, and Switzerland. Submission of the Annual Report on the progress of the PROOF clinical trial for the period 4 June 2021 to 3 June 2022. PROOF is a clinical trial entitled Penumbral Rescue by Normobaric O=O Administration in Patients with Ischemic Stroke and Target Mismatch ProFile: A Phase II Proof-of-Concept Trial. SÚKL granted permission for the clinical trial on 26/09/2018. Clinical evaluation takes place in the Czech Republic at St. Anne´s University Hospital Brno (6 patients) and University Hospital Královské Vinohrady in Prague (no patients). The last valid version of the protocol is version 1.4 from 17/3/2021. During April and May 2022, an interim analysis of the clinical trial took place, after its evaluation on 13/05/2022, the Data and Safety Monitoring Board came to the opinion not to continue with the clinical trial. With immediate effect, the contracting authority issued an instruction to end the recruitment of patients in the centers. The clinical trial was terminated with the patient's last visit at St. Anne´s University Hospital Brno in August 2022. |
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