Use of rFXIII in Treatment of Congenital FXIII Deficiency, a Prospective Multi-centre Observational Study
Public ClinicalTrials.gov record NCT01862367. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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®.
Study identification
- NCT ID
- NCT01862367
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 30 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 17, 2013 (Actual)
- Primary completion
- Jun 26, 2019 (Actual)
- Completion
- Jun 26, 2019 (Actual)
- Last update posted
- Jul 9, 2019
2013 – 2019
United States locations
- U.S. sites
- 7
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novo Nordisk Investigational Site | Orange | California | 92868 | — |
| Novo Nordisk Investigational Site | Tampa | Florida | 33607 | — |
| Novo Nordisk Investigational Site | Atlanta | Georgia | 30322 | — |
| Novo Nordisk Investigational Site | Detroit | Michigan | 48201 | — |
| Novo Nordisk Investigational Site | Minneapolis | Minnesota | 55404 | — |
| Novo Nordisk Investigational Site | Cleveland | Ohio | 44106 | — |
| Novo Nordisk Investigational Site | Columbus | Ohio | 43205 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01862367, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 9, 2019 · Synced Nov 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01862367 live on ClinicalTrials.gov.