Safety of a Single Intravenous Dose of Recombinant Factor XIII in Children With Congenital FXIII A-subunit Deficiency (mentor™4)
A Phase 3b Trial Investigating the Pharmacokinetics and Safety Profile of a Single Intravenous Dose of rFXIII in Paediatric (1 to Less Than 6 Years Old) Subjects With Congenital FXIII A-subunit Deficiency
Sponsor: Novo Nordisk A/S
This PHASE3 trial investigates Congenital Bleeding Disorder and Congenital FXIII Deficiency and is currently completed. Novo Nordisk A/S leads this study, which shows 10 recorded versions since 2010 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Status Flow
Change History
10 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Jan 2023 — Jul 2024 [monthly]
Completed PHASE3
-
Dec 2022 — Jan 2023 [monthly]
Completed PHASE3
▶ Show 5 earlier versions
-
Jan 2021 — Dec 2022 [monthly]
Completed PHASE3
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
-
May 2017 — Jun 2018 [monthly]
Completed PHASE3
-
Feb 2017 — May 2017 [monthly]
Completed PHASE3
-
Jan 2017 — Feb 2017 [monthly]
Completed PHASE3
First recorded
Nov 2010
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Novo Nordisk A/S
For direct contact, visit the study record on ClinicalTrials.gov .