A Study of BAX 888 in Male Adults With Severe Hemophilia A (NCT03370172) | Clinical Trial Compass
CompletedPhase 1/2
A Study of BAX 888 in Male Adults With Severe Hemophilia A
United States4 participantsStarted 2018-02-27
Plain-language summary
The main aim of this study is to check if there are side effects from BAX 888 and to determine the dose of BAX 888 for treating severe hemophilia A in male adults.
Participants will receive one infusion with BAX 888 at the hemophilia treatment center. During the study, participants will visit their study clinic multiple times.
Who can participate
Age range18 Years – 75 Years
SexMALE
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Inclusion Criteria:
* Male, aged 18 to 75 years at the time of screening.
* Established severe hemophilia A (FVIII:C \<1%, measured following \>=5 days without FVIII treatment) and/or documented intron 1 inversion or intron 22 inversion mutation in the F8 gene, consistent with severe hemophilia A , and documented evidence of \>=3 hemorrhages over the previous 12 months requiring treatment with exogenous FVIII or use of FVIII prophylaxis because of history of frequent bleeding episodes.
* History of greater than (\>) 150 exposure days to exogenously administered FVIII concentrates or cryoprecipitate.
* Sexually active men must agree to use barrier contraception (combination of a condom and spermicide) or limit sexual intercourse to post-menopausal, surgically sterilized, or contraception-practicing partners for a minimum of 6 months after administration of BAX 888, or until BAX 888 genomes are no longer detected in the semen, whichever is sooner.
* Participant is willing and able to comply with the requirements of the protocol, including provision of semen samples, maintenance of a diary of bleeding episodes and FVIII protein use.
* Signed informed consent.
Exclusion Criteria:
* Bleeding disorder(s) other than hemophilia A.
* Personal laboratory evidence of having developed inhibitors to FVIII protein at any time (\>=0.6 Bethesda units \[BU\] on any single test).
* Documented prior allergic reaction to any FVIII product.
* Anti-Adeno-associated virus, serotype 8 (AAV8) neut…
What they're measuring
1
Number of Participants With BAX 888-Related Adverse Events (AEs)
Timeframe: From first dose up to end of the study (approximately 6 years)