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In this observational study researchers want to learn more about the safety of drug Jivi over a long period of time. Jivi (generic name: Damoctocog alfa pegol) is an approved blood clotting Factor VIII (FVIII) medication for the treatment of hemophilia A (bleeding disorder resulting from a lack of FVIII). It is manufactured via recombinant technology and has an extended half-live, i.e. it will stay longer in the body than other FVIII products. Therefore Jivi acts longer in the body which reduces the frequency of drug injections. This study will enroll previously treated patients with hemophilia A who are receiving Jivi regularly at their treating doctors to prevent bleeding. Observation for each patient will last for at least 4 years, and medical data will be collected during patients' routine visits at their treating doctors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Damoctocog alfa pegol | Participants with hemophilia A received damoctocog alfa pegol as prophylaxis treatment prescribed by the physician as part of normal clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Damoctocog alfa pegol (Jivi, BAY94-9027) | Drug | Different prophylaxis regimens with damoctocog alfa pegol following approved local labels or any other regimen prescribed by the physician as part of normal clinical practice |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with safety events | At least 4 years | |
| Duration of safety events | At least 4 years | |
| Number of participants with safety events leading to a change of treatment | At least 4 years | |
| Number of participants with safety events per intensity | The maximum intensity of each safety event should be assigned to one of the following categories: mild, moderate or severe | At least 4 years |
| Number of participants with safety events with outcome of death | At least 4 years | |
| Number of participants with safety events related to inhibitor development | At least 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse reactions (ARs) that are defined within the system organ classes nervous system and psychiatric disorders | At least 4 years | |
| Number of adverse reactions (ARs) related to hepatic or renal function | At least 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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All previously treated patients (PTPs) with hemophilia A receiving prophylaxis with damoctocog alfa pegol will be eligible to be enrolled in the study. Indications and contra-indications according to the local market authorization will be carefully considered
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Multiple Locations | Austria | ||||
| Many Locations |
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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| Change from baseline in creatinine | At least 4 years |
| Change from baseline in estimated glomerular filtration rate (eGFR) | At least 4 years |
| Change from baseline in alanine transaminase (ALT) | At least 4 years |
| Change from baseline in aspartate aminotransferase (AST) | At least 4 years |
| Change from baseline in bilirubin | At least 4 years |
| Testing for PEG plasma levels (baseline and end of study) | PEG (Polyethylene Glycol)-plasma levels at baseline and end of study will be analyzed only if PEG-plasma levels were collected in local routine clinical practice at the investigator's discretion. | At least 4 years |
| Number of patients with abnormal findings as assessed by neurological examination | At least 4 years |
| Multiple Locations |
| Germany |
| Many Locations | Multiple Locations | Greece |
| Many Locations | Multiple Locations | Italy |
| Many Locations | Multiple Locations | Slovenia |
| Many Locations | Multiple Locations | Spain |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D005169 | Factor VIII |
| ID | Term |
|---|---|
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
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