Hemophilia Clinical Trial
Official title:
A Multicenter, Non-randomized, Open-label, Multiple Dose Escalation Study to Evaluate the Safety and Tolerability of Subcutaneous BAY1093884 in Males With Severe Hemophilia
Verified date | October 2019 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to investigate the safety of a test drug to treat hemophilia in adult men.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 31, 2020 |
Est. primary completion date | May 29, 2020 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Participants with hemophilia A and FVIII activity <1% or hemophilia B with FIX activity <2% - Participants must be currently without inhibitors or with low titer inhibitors (inhibitor titer < 5 Bethesda units) who are receiving current on demand treatment with any FVIII or FIX (recombinant or plasma-derived; modified or unmodified) Exclusion Criteria: - History or at risk of developing diseases related to venous thromboembolic events (e.g., pulmonary embolism, deep vein thrombosis or thrombophlebitis) - History of any other clinically relevant coagulation disorder (particularly disseminated intravascular coagulopathy or combined FVIII/Factor V deficiency) or platelet disorder - History or at risk of developing cardiac, coronary and/or arterial peripheral atherosclerotic disease and/or arterial thromboembolic events, particularly myocardial infarction, cerebrovascular accident, stroke, transient ischemic attack, congestive heart failure, angina pectoris, treatment for angina pectoris or uncontrolled hypertension - History or at risk for thrombotic microangiopathy |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of drug-related adverse events | Up to 3 months | ||
Primary | Frequency of drug-related serious adverse events | Up to 3 months | ||
Primary | Frequency of adverse events of special interest | Adverse events of special interest comprise thromboembolic and thrombotic microangiopathy events, and hypersensitivity reactions. | Up to 3 months |
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