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 after 12 months, compared to the 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.
The phase 3 BASIS Trial was designed to include the following objectives about HYMPAVZI: (1) if 12 months of HYMPAVZI treatment works better than previous on-demand factor treatments to reduce bleeding (ie, is HYMPAVZI superior?) and (2) if 12 months of HYMPAVZI treatment to reduce bleeding is just as effective as routine (factor prophylactic) treatments (ie, is HYMPAVZI noninferior?).
HYMPAVZI delivered proven bleed protection
Primary objective
Reduced treated bleeds
HYMPAVZI reduced the number of treated bleeding episodes in the clinical trial.
ABR of treated bleeds with HYMPAVZI:
lower than on-demand
(3.20 ABR vs 39.86 ABR)
ABR of treated bleeds with HYMPAVZI:
lower than routine
prophylaxis
(5.09 ABR vs 7.90 ABR)
Secondary objective
Reduced joint bleeds
ABR of joint bleeds with HYMPAVZI:
lower than on-demand
(2.85 ABR vs 34.52 ABR)
ABR of joint bleeds with HYMPAVZI:
lower than routine
prophylaxis
(4.13 ABR vs 5.69 ABR)
Secondary objective
Reduced 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 24.38 ABR)
ABR of target joint bleeds with HYMPAVZI:
lower than routine
prophylaxis
(2.51 ABR vs 3.37 ABR)
Secondary objective
Reduced spontaneous bleeds
ABR of spontaneous bleeds with HYMPAVZI:
lower than on-demand
(2.45 ABR vs 32.63 ABR)
ABR of spontaneous bleeds with HYMPAVZI:
lower than routine
prophylaxis
(3.78 ABR vs 5.89 ABR)
Secondary objective
Reduced total bleeds
Total bleeds included treated and untreated bleeds.
ABR of total bleeds with HYMPAVZI:
lower than on-demand
(7.41 ABR vs 49.97 ABR)
ABR of total bleeds with HYMPAVZI:
lower than routine
prophylaxis
(5.98 ABR vs 8.90 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.