Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants must be ≥ 12 years of age inclusive, at the time of signing the informed consent/assent.
Previously treated patients (≥ 150 EDs) with congenital hemophilia A.
Prophylaxis with any SHL FVIII product with a stable frequency for at least 6 consecutive months within the last 12 months prior to screening before entering the study and documented in medical records. Stable frequency is defined as a minimum 18 weeks of treatment in a 6 (consecutive) calendar month period in the 12 months prior to screening. Patients can be on any non-Jivi EHL between the 6-month stable SHL prophylaxis period and start of study treatment.
Documented bleeding rate (ABR) while on stable frequency SHL prophylaxis for at least 6 consecutive months within the last 12 months prior to screening.
No current evidence (≥ 0.6 BU/mL) of FVIII inhibitors. If a participant has had a positive inhibitor titer in the past (≥ 0.6 BU/mL on two occasions) but has been tolerized for at least 1 year since the last positive titer with at least 1 negative inhibitor assay test during that period, they can be enrolled. If a participant has had a positive inhibitor titer in the past (≥ 0.6 BU/mL) but did not require tolerization and has had at least 1 negative inhibitor assay test during a minimum period of at least 1 year since the last positive titer, they can be enrolled.
If they are human immunodeficiency virus (HIV) positive, cluster of differentiation 4 (CD4+) lymphocyte count should be \> 200/mm\^3 within 1 year before entering the study and documented in medical records. -
Participants who are willing to complete an electronic diary (eDiary).
Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
For adolescent participants (≥ 12 to \< 18 years), a legal guardian must be available to help the study-site personnel ensure follow-up; accompany the participant to the study site on each assessment day according to the Schedule of Activities (SoA) (e.g. able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures); consistently and consecutively be available to provide information on the participant using the PROs during the scheduled study visits; accurately and reliably dispense study intervention as directed.
For adolescent participants, a legal guardian must be able to accurately maintain the child's take-home record, including items of general health.
You may not be if
Any other inherited or acquired bleeding disorder in addition to hemophilia A. Note: von Willebrand disease should be diagnosed per local clinical practice. Participants with a diagnosis of von Willebrand disease in medical records or diagnosed at the time of screening will be excluded.
Platelet count \< 100,000/mm\^3
Evidence of inhibitor to FVIII (≥ 0.6 BU/mL) within the last 1 year
The participant is currently participating in another investigational drug study or has participated in a clinical study involving an investigational drug or device within 30 days of signing informed consent.
The participant has a planned major surgery.
Documentation of missing risk score parameters other than physical activity .
Known hypersensitivity to the drug substance, excipients, or mouse or hamster protein.
Any other significant medical condition that the investigator feels would be a risk to the participant or would impede the study.
Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g. employee or student of the investigational site).
Otherwise vulnerable participants (e.g. participants who are in custody by order of an authority).
Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures (i.e. eDiary completion, clinic visits, phone updates), restrictions, and requirements.
Clareo Health | Prophylaxis Regimen for Hemophilia A Patients
