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NCT01230021 · ClinicalTrials.gov registry record · Phase 3
Safety of a Single Intravenous Dose of Recombinant Factor XIII in Children With Congenital FXIII A-subunit Deficiency
A Phase 3 study, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 6
- Enrollment target
NCT01230021: Completed Phase 3 study, sponsored by Novo Nordisk A/S.
NCT01230021 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 6 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01230021, a Phase 3 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 6 participants
- Enrollment target
Study Summary
This trial is conducted in Europe and United States of America (USA). The aim of this clinical trial is to investigate the pharmacokinetics (at which rate the substance is distributed and eliminated from the body) and the safety profile of catridecacog (recombinant factor XIII (rFXIII)) in children with congenital FXIII A-subunit deficiency. Young children (1 to less than 6 years old) with congenital FXIII deficiency are evaluated.
Primary Outcome
A measure of the exposure. Blood samples for the PK assessment were drawn pre-dose and up to 30 days after dosing. The PK of FXIII in children was assessed after a single i.v. dose of rFXIII 35 IU/kg.
Interventions
- DRUG catridecacog
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2010-11 |
| Est. Completion | 2012-01 |
| Phase | Phase 3 |
What the finished NCT01230021 record still lists
NCT01230021 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which catridecacog is the first listed.
NCT01230021 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01230021 about?
NCT01230021 is a clinical study titled "Safety of a Single Intravenous Dose of Recombinant Factor XIII in Children With Congenital FXIII A-subunit Deficiency". This trial is conducted in Europe and United States of America (USA). The aim of this clinical trial is to investigate the pharmacokinetics (at which rate the substance is distributed and eliminated from the body) and the safety profile of catridecacog (recombinant factor XIII (rFXIII)) in children ...
What is the current status of trial NCT01230021?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 6 participants. The study started on 2010-11. Estimated completion is 2012-01.
What interventions are being tested in trial NCT01230021?
The interventions under investigation include: catridecacog (DRUG).
Who is sponsoring clinical trial NCT01230021?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01230021's enrollment target sits among peer trials
6 1995th of 2000 higher than 4 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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