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NCT01862367 · ClinicalTrials.gov registry record
Use of rFXIII in Treatment of Congenital FXIII Deficiency, a Prospective Multi-centre Observational Study
A clinical trial, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- 30
- Enrollment target
NCT01862367: Completed study, sponsored by Novo Nordisk A/S.
NCT01862367 is a clinical trial that has completed, run by Novo Nordisk A/S. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01862367 has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- 30 participants
- Enrollment target
Study Summary
This study is conducted globally. The aim of this observational study is to investigate the incidence of specific adverse drug reactions associated with the use of recombinant factor XIII (NovoThirteen®) in patients with congenital FXIII A-subunit deficiency (congenital FXIII deficiency), comprising FXIII antibodies, allergic reactions, embolic and thrombotic events and lack of therapeutic effect. The study will aim at observing all patients exposed to NovoThirteen® in the EU, and additional patients from selected non-EU countries. Recombinant FXIII (rFXIII) is registered in EU and Switzerland as NovoThirteen® and in Canada as Tretten®.
Interventions
- DRUG catridecacog
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2013-05-17 |
| Est. Completion | 2019-06-26 |
What the finished NCT01862367 record still lists
NCT01862367 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which catridecacog is the first listed.
NCT01862367 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01862367 about?
NCT01862367 is a clinical study titled "Use of rFXIII in Treatment of Congenital FXIII Deficiency, a Prospective Multi-centre Observational Study". This study is conducted globally. The aim of this observational study is to investigate the incidence of specific adverse drug reactions associated with the use of recombinant factor XIII (NovoThirteen®) in patients with congenital FXIII A-subunit deficiency (congenital FXIII deficiency), comprising...
What is the current status of trial NCT01862367?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2013-05-17. Estimated completion is 2019-06-26.
What interventions are being tested in trial NCT01862367?
The interventions under investigation include: catridecacog (DRUG).
Who is sponsoring clinical trial NCT01862367?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
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