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PASS) Information Reference Number: RD-SOP-1214 Supplement Version: 14 Post Authorization Safety Study (PASS) Information HA-SAFE: Observational study evaluating long-term safety Acronym/Title of real-world treatment with damoctocog alfa pegol in previously treated patients with hemophilia A Protocol version and date v 1.0, 13 JAN 2020 IMPACT study number 20904 Study type / Study phase Observational, post-approval PASS Joint PASS: YES NO EU PAS register number Study not yet registered Active substance ATC code: B02BD02/Hematological/Damoctocog alfa pegol Medicinal product Jivi EU/1/18/1324/001 Jivi 250 IU; Product reference EU/1/18/1324/002 Jivi 500 IU; EU/1/18/1324/003 Jivi 1000 IU; EU/1/18/1324/004 Jivi 2000 IU; EU/1/18/1324/005 Jivi 3000 IU Procedure number EMEA/H/C/004054 Study Initiator and Funder Bayer Consumer Care AG, Basel, Switzerland Research question and objectives The aim of this study is to characterize in a real-world setting the long-term safety of damoctocog alfa pegol drug usage. The primary objective of this study is to assess the long- term safety of prophylaxis with damoctocog alfa pegol in patients with hemophilia A in the real-world setting through the collection and analysis of adverse events (AEs) of special interest including those potentially indicative of PEG accumulation (hypersensitivity reactions, loss of drug effect, renal impairment, neurocognitive disorders, and inhibitor development), AEs, serious adverse events (SAEs), and adverse reactions (ARs). The secondary objective is to monitor the clinical effects of long-term exposure of prophylaxis damoctocog alfa pegol in 20904; HA-SAFE; v 1.0, 13 JAN 2020 Page 1 of 48 Reference Number: RD-SOP-1214 Supplement Version: 14 patients with hemophilia A, including assessments of kidney and liver function parameters, neurological function and patients’ PEG plasma levels. Country(-ies) of study The study will be conducted in Europe, countries are not yet identified. Potential countries are Austria Belgium/Luxemburg, Finland, Germany, Greece, Italy, Netherlands, Portugal, Scandinavia (Denmark, Norway, and Sweden), Slovenia, Spain, and Switzerland. The study may also be conducted in other countries not currently listed. Author PPD PPD Marketing authorization holder Marketing authorization Bayer AG holder(s) 51368 Leverkusen, Germany MAH contact person PPD PPD PPD The study will be conducted in compliance with the protocol and any applicable regulatory requirements. Throughout this document, symbols indicating proprietary names (®, TM) may not be displayed. Hence, the appearance of product names without these symbols does not imply that these names are not protected. 20904; HA-SAFE; v 1.0, 13 JAN 2020 Page 2 of 48 Reference Number: RD-SOP-1214 Supplement Version: 14 1. Table of contents 1. Table of contents ................................................................................................................ 3 2. List of abbreviations .......................................................................................................... 5 3. Responsible parties ............................................................................................................ 7 3.1 Study initiator and funder ................................................................................................. 7 3.2 Collaborators/Committees ................................................................................................ 8 4. Abstract ............................................................................................................................... 9 5. Amendments ..................................................................................................................... 13 6. Milestones ......................................................................................................................... 13 7. Rationale and background .............................................................................................. 14 7.1 Epidemiology, classification, and treatment of hemophilia A ....................................... 14 7.2 Rationale ......................................................................................................................... 14 7.3 Background ..................................................................................................................... 15 8. Research questions and objectives ................................................................................. 15 8.1 Primary objective ............................................................................................................ 15 8.2 Secondary objective(s) ................................................................................................... 16 9. Research methods ............................................................................................................ 16 9.1 Study design ................................................................................................................... 16 9.1.1 Primary endpoint ......................................................................................................... 17 9.1.2 Secondary endpoints ................................................................................................... 17 9.2 Setting ............................................................................................................................. 17 9.2.1 Eligibility ..................................................................................................................... 17 9.2.1.1 Inclusion criteria ...................................................................................................... 17 9.2.1.2 Exclusion criteria ..................................................................................................... 18 9.2.2 Withdrawal .................................................................................................................. 18 9.2.3 Replacement ................................................................................................................ 18 9.2.4 Representativeness ...................................................................................................... 18 9.2.5 Visits ............................................................................................................................ 19 9.3 Variables ......................................................................................................................... 21 9.3.1 Variables to determine the primary endpoint .............................................................. 22 9.3.2 Variables to determine the secondary endpoints ......................................................... 23 9.4 Data sources .................................................................................................................... 23 9.5 Study size ........................................................................................................................ 23 9.6 Data management ........................................................................................................... 24 9.7 Data analysis ................................................................................................................... 24 9.7.1 Statistical considerations ............................................................................................. 24 9.7.2 Analysis of population characteristics ......................................................................... 25 9.7.3 Analysis of primary variable(s) ................................................................................... 25 9.7.4 Analysis of secondary variables .................................................................................. 26 9.7.5 Analysis of safety data ................................................................................................ 26 9.8 Quality control ................................................................................................................ 26 20904; HA-SAFE; v 1.0, 13 JAN 2020 Page 3 of 48 Reference Number: RD-SOP-1214 Supplement Version: 14 9.8.1 Data quality ................................................................................................................. 26 9.8.2 Quality review ............................................................................................................. 27 9.8.3 Storage of records and archiving ................................................................................. 27 9.8.4 Certification/qualification of external parties ............................................................. 27 9.9 Limitations of the research methods ............................................................................... 28 9.10 Other aspects ................................................................................................................... 28 10. Protection of human subjects .......................................................................................... 28 10.1 Ethical conduct of the study ........................................................................................... 28 10.2 Regulatory authority approvals/authorizations ............................................................... 28 10.3 Independent ethics committee (IEC) or institutional review board (IRB) ..................... 29 10.4 Patient information and consent ..................................................................................... 29 10.5 Patient insurance ............................................................................................................
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