Author: Marty, Francisco M; Chemaly, Roy F; Mullane, Kathleen M; Lee, Dong-Gun; Hirsch, Hans H; Small, Catherine B; Bergeron, Anne; Shoham, Shmuel; Ljungman, Per; Waghmare, Alpana; Blanchard, Elodie; Kim, Yae-Jean; McKevitt, Matt; Porter, Danielle P; Jordan, Robert; Guo, Ying; German, Polina; Boeckh, Michael; Watkins, Timothy R; Chien, Jason W; Dadwal, Sanjeet S
Title: A Phase 2b, Randomized, Double-blind, Placebo-Controlled Multicenter Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of Presatovir in Hematopoietic Cell Transplant Recipients with Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract Document date: 2019_12_3
ID: sl45z4i0_6
Snippet: The study followed the International Conference on Harmonisation Good Clinical Practice guidelines and the principles of the Declaration of Helsinki and was approved by local ethics committees. Written informed consent was obtained from patients or legally responsible representatives. Data Monitoring Committee activities and changes to the study protocol are described in Supplemental methods. This trial was registered with ClinicalTrials.gov (NCT.....
Document: The study followed the International Conference on Harmonisation Good Clinical Practice guidelines and the principles of the Declaration of Helsinki and was approved by local ethics committees. Written informed consent was obtained from patients or legally responsible representatives. Data Monitoring Committee activities and changes to the study protocol are described in Supplemental methods. This trial was registered with ClinicalTrials.gov (NCT02254421) and EudraCT (2014-002475-29) before enrollment began.
Search related documents:
Co phrase search for related documents- ethic committee and local ethic committee: 1, 2, 3, 4
Co phrase search for related documents, hyperlinks ordered by date