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Bleed protection in those ages 6 to less than 18
HYMPAVZI is being studied in children, including those ages 6 to less than 18 with hemophilia A and B, with or without inhibitors
HYMPAVZI was studied in the BASIS clinical trial and is being studied in the BASIS KIDS clinical trial. The 2 studies included distinct groups of people and had different objectives. There is some overlap in age of people between studies (12 to less than 18 years old).
BASIS KIDS study objectives
The primary objective is to evaluate the annualized bleed rate (ABR) of treated bleeds after 12 months of treatment with HYMPAVZI.
The secondary objectives of the study include evaluation of HYMPAVZI prophylaxis based on the occurrences of treated joint bleeds, treated target joint bleeds, treated spontaneous bleeds, and total bleeds. BASIS KIDS is an ongoing clinical study.
Frequency and severity of adverse events and serious adverse events observed with HYMPAVZI are also being studied.
BASIS KIDS Pre-Study Background
The efficacy of HYMPAVZI was based upon the ABR of treated bleeds of patients ages 6 to less than 18 during treatment with HYMPAVZI prophylaxis compared to past patient records collected in the 12 months before HYMPAVZI treatment.
- The ABR of treated bleeds for patients without inhibitors was 3.6, based on 12-month past bleeding history
- The ABR of treated bleeds for patients with inhibitors was 18.9, based on 12-month past bleeding history
See the results of the BASIS KIDS study*
BASIS KIDS study results—without inhibitors (n=36)
Without Inhibitors
Primary objective
Treated bleeds
Secondary objective
Joint bleeds [treated]
Target joint bleeds [treated]
Spontaneous bleeds [treated]
Total bleeds [treated and untreated]
The mean is the average of a set of numbers. The median is the middle value in a set of numbers arranged from smallest to largest.
BASIS KIDS study results—with inhibitors (n=14)
With Inhibitors
Primary objective
Treated bleeds
Secondary objective
Joint bleeds [treated]
Target joint bleeds [treated]
Spontaneous bleeds [treated]
Total bleeds [treated and untreated]
The mean is the average of a set of numbers. The median is the middle value in a set of numbers arranged from smallest to largest.
BASIS KIDS study results—without inhibitors (n=22)
Without Inhibitors
Primary objective
Treated bleeds
Secondary objective
Joint bleeds [treated]
Target joint bleeds [treated]
Spontaneous bleeds [treated]
Total bleeds [treated and untreated]
The mean is the average of a set of numbers. The median is the middle value in a set of numbers arranged from smallest to largest.
BASIS KIDS study results—with inhibitors (n=7)
With Inhibitors
Primary objective
Treated bleeds
Secondary objective
Joint bleeds [treated]
Target joint bleeds [treated]
Spontaneous bleeds [treated]
Total bleeds [treated and untreated]
The mean is the average of a set of numbers. The median is the middle value in a set of numbers arranged from smallest to largest.
BASIS KIDS study results—without inhibitors (n=14)
Without Inhibitors
Primary objective
Treated bleeds
Secondary objective
Joint bleeds [treated]
Target joint bleeds [treated]
Spontaneous bleeds [treated]
Total bleeds [treated and untreated]
The mean is the average of a set of numbers. The median is the middle value in a set of numbers arranged from smallest to largest.
BASIS KIDS study results—with inhibitors (n=7)
With Inhibitors
Primary objective
Treated bleeds
Secondary objective
Joint bleeds [treated]
Target joint bleeds [treated]
Spontaneous bleeds [treated]
Total bleeds [treated and untreated]
The mean is the average of a set of numbers. The median is the middle value in a set of numbers arranged from smallest to largest.
Before a child under your care starts using HYMPAVZI, it is very important to talk to their doctor about using factor VIII and factor IX products or bypassing agents while using HYMPAVZI. The child may be prescribed factor VIII or factor IX medicines or bypassing agents to treat episodes of breakthrough bleeding while using HYMPAVZI. Carefully follow healthcare provider instructions regarding when to use these medicines and the prescribed dose during their treatment with HYMPAVZI. Do not use additional doses of HYMPAVZI to treat breakthrough bleeds.
*Data shown for BASIS KIDS were based on an interim analysis.
†In the BASIS study, patients ages 12+ without inhibitors achieved a 92% reduction in treated bleeds on HYMPAVZI compared with on-demand factor-based treatment (3.2 ABR vs 39.9 ABR) and a 35% reduction in treated bleeds on HYMPAVZI compared with routine factor-based prophylaxis treatment (5.1 ABR vs 7.9 ABR). Patients ages 12+ with inhibitors achieved a 93% reduction in treated bleeds on HYMPAVZI compared with on-demand bypassing agent treatment (1.4 ABR vs 19.8 ABR).
