Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579144
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
Pharmacokinetic Comparison of Efanesoctocog Alfa vs Other EHL-rFVIII Products in Participants With Severe Haemophilia A
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Multicentre Study to Compare the Pharmacokinetics of Efanesoctocog Alfa Versus rFVIII Products Damactocog Alfa Pegol or Turoctocog Alfa Pegol After a Single Intravenous Dose of 50 IUkg in a Fixed Sequence in Previously Treated Adults With Severe Haemophilia A
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
SobiBIVV001-003 is an open-label 2-period fixed sequence study for intra-participant comparison of the PK profiles of efanesoctocog alfa and the extended half-life rFVIII products damactocog alfa pegol or turoctocog alfa pegol after a single iv injection in previously treated males 18-65 years of age with severe haemophilia A
Participants who are receiving treatment with damoctocog alfa pegol n12 or turoctocog alfa pegol n12 will be enrolled in the study The study will start with a screening period up to 28 days including a wash-out period prior to start of the actual study period
During the the first visit a single dose of damactocog alfa pegol or turoctocog alfa pegol corresponding to the participants pre-study treatment will be administered A PK sampling period will follow over 7 visits Following completion of the PK sampling of the original treatment regimen the patients will be given a single dose of efanesoctocog alfa at visit 8 after which a new PK sampling period will follow visit 8-15
The primary objective for the study is to compare the half-life of efanesoctocog alfa with that of the two comparator drugs after a single iv injections
Secondary objectives include comparison of area under the curve for efanesoctocog alfa vs the two comparator drugs characterization of PK parameters for all three drugs as well as well as to evaluate safety and tolerability of a single iv injection of efanesoctocog alfa
Participants who are receiving treatment with damoctocog alfa pegol n12 or turoctocog alfa pegol n12 will be enrolled in the study The study will start with a screening period up to 28 days including a wash-out period prior to start of the actual study period
During the the first visit a single dose of damactocog alfa pegol or turoctocog alfa pegol corresponding to the participants pre-study treatment will be administered A PK sampling period will follow over 7 visits Following completion of the PK sampling of the original treatment regimen the patients will be given a single dose of efanesoctocog alfa at visit 8 after which a new PK sampling period will follow visit 8-15
The primary objective for the study is to compare the half-life of efanesoctocog alfa with that of the two comparator drugs after a single iv injections
Secondary objectives include comparison of area under the curve for efanesoctocog alfa vs the two comparator drugs characterization of PK parameters for all three drugs as well as well as to evaluate safety and tolerability of a single iv injection of efanesoctocog alfa
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None