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NCT01779921 · ClinicalTrials.gov registry record
Treatment of Congenital Factor VII Deficiency
A clinical trial, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- 163
- Enrollment target
NCT01779921: Completed study, sponsored by Novo Nordisk A/S.
NCT01779921 is a clinical trial that has completed, run by Novo Nordisk A/S. The registered enrollment target is 163 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01779921 has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- 163 participants
- Enrollment target
Study Summary
This study is conducted globally. The aim of this study is to describe the treatment modalities and outcomes of bleeding episodes, surgery and prophylaxis in patients with factor VII (FVII) deficiency in addition to evaluate the presence (in already treated patients) and/or the appearance of inhibiting antibodies to FVII and/or therapy-related thrombosis. Due to a Novo Nordisk commitment to the Committee for Medicinal Products for Human Use (CHMP), Novo Nordisk receives data on treatment with activated recombinant human FVII (rFVIIa, NovoSeven®) in patients with FVII deficiency from the Seven Treatment Evaluation Registry (STER, NCT01269138). These patients can also have been treated with other haemostatics for systemic administration.
Interventions
- DRUG activated recombinant human factor VII
- DRUG Fresh frozen plasma (Source unspecified)
- DRUG Plasma-derived FVII (LFB)
- DRUG Prothrombin Complex conc. (PCC)
- DRUG Plasma-derived FVII conc. (pdFVII Baxter)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2005-10 |
| Est. Completion | 2012-01 |
What the finished NCT01779921 record still lists
NCT01779921 is an observational study that tracks outcomes without assigning an intervention. The registered 163 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 5 interventions - of which activated recombinant human factor VII is the first listed.
NCT01779921 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01779921 about?
NCT01779921 is a clinical study titled "Treatment of Congenital Factor VII Deficiency". This study is conducted globally. The aim of this study is to describe the treatment modalities and outcomes of bleeding episodes, surgery and prophylaxis in patients with factor VII (FVII) deficiency in addition to evaluate the presence (in already treated patients) and/or the appearance of inhibit...
What is the current status of trial NCT01779921?
This trial is currently completed. The enrollment target is 163 participants. The study started on 2005-10. Estimated completion is 2012-01.
What interventions are being tested in trial NCT01779921?
The interventions under investigation include: activated recombinant human factor VII (DRUG), Fresh frozen plasma (Source unspecified) (DRUG), Plasma-derived FVII (LFB) (DRUG), Prothrombin Complex conc. (PCC) (DRUG), Plasma-derived FVII conc. (pdFVII Baxter) (DRUG).
Who is sponsoring clinical trial NCT01779921?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
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