Not actual patients.
Study results
Explore the data from the clinical trial
What was studied
The primary objective of the trial focused on the annualized bleed rate (ABR) of treated bleeds during treatment with HYMPAVZI, compared to the mean ABR of factor-based on-demand and routine prophylactic treatment in patients.
The secondary objective of the study included evaluation of HYMPAVZI prophylaxis (compared with on-demand and routine prophylactic factor-based treatment) based on the incidences of treated joint bleeds, treated target joint bleeds, treated spontaneous bleeds, and total bleeds.
HYMPAVZI delivered proven bleed protection
Primary objective
Fewer treated bleeds
HYMPAVZI reduced the number of treated bleeding episodes in the clinical trial.
ABR of treated bleeds with HYMPAVZI:
lower than on-demand
(3.18 ABR vs 38.00 ABR)
ABR of treated bleeds with HYMPAVZI:
lower than routine
prophylaxis
(5.08 ABR vs 7.85 ABR)
Secondary objective
Fewer joint bleeds
ABR of joint bleeds with HYMPAVZI:
lower than on-demand
(2.83 ABR vs 32.86 ABR)
ABR of joint bleeds with HYMPAVZI:
lower than routine
prophylaxis
(4.13 ABR vs 5.66 ABR)
Secondary objective
Fewer target joint bleeds
If a joint has had 3+ bleeds in a span of 6 months, it's considered a target joint.
ABR of target joint bleeds with HYMPAVZI:
lower than on-demand
(1.84 ABR vs 23.18 ABR)
ABR of target joint bleeds with HYMPAVZI:
lower than routine
prophylaxis
(2.51 ABR vs 3.36 ABR)
Secondary objective
Fewer spontaneous bleeds
ABR of spontaneous bleeds with HYMPAVZI:
lower than on-demand
(2.44 ABR vs 30.93 ABR)
ABR of spontaneous bleeds with HYMPAVZI:
lower than routine
prophylaxis
(3.78 ABR vs 5.86 ABR)
Secondary objective
Fewer total bleeds
ABR of total bleeds with HYMPAVZI:
lower than on-demand
(7.39 ABR vs 47.76 ABR)
ABR of total bleeds with HYMPAVZI:
lower than routine
prophylaxis
(5.97 ABR vs 8.84 ABR)
Before you start using HYMPAVZI, it is very important to talk to your doctor about using factor VIII and factor IX products while using HYMPAVZI.*
- You may need to use factor VIII or factor IX products to treat episodes of breakthrough bleeding while using HYMPAVZI. Carefully follow your healthcare provider’s instructions regarding when and how to use factor VIII or factor IX products while using HYMPAVZI. Individual results may vary.