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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 is a clinical trial that has completed, run by Novo Nordisk A/S. The registered enrollment target is 30 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01862367
The ClinicalTrials.gov registry entry for NCT01862367 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which catridecacog is the first listed.
NCT01862367 reports 0 study locations.
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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