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NCT02448680 · ClinicalTrials.gov registry record · Phase 3
A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa
A Phase 3 study of Hemophilia A With Inhibitors and Hemophilia B With Inhibitors, sponsored by Laboratoire français de Fractionnement et de Biotechnologies.
- Completed
- Registry status
- Phase 3
- Development phase
- 25
- Enrollment target
- 9
- Study locations
NCT02448680 is a Phase 3 study of Hemophilia A With Inhibitors and Hemophilia B With Inhibitors that has completed, run by Laboratoire français de Fractionnement et de Biotechnologies. The registered enrollment target is 25 participants. The trial reports 9 study locations across 4 states.
The verdict
NCT02448680, a Phase 3 study of Hemophilia A With Inhibitors and Hemophilia B With Inhibitors, has completed, sponsored by Laboratoire français de Fractionnement et de Biotechnologies.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 25 participants
- Enrollment target
- 9
- Study locations
Study Summary
The purpose of the study is to assess the safety, efficacy and pharmacokinetics of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or IX in 12 patients ( birth to \<6 years old), and 12 patients (≥6 years old to \<12 years old).
Conditions Studied
Interventions
- BIOLOGICAL Coagulation FVIIa (Recombinant)
Study Locations (9)
Other
- University Multiprofile Hospital for Active Treatment "Sveti Georgi" - Plovdiv
- University Hospital Motol - Prague
- Hematology of Department Hemophilia and Thromboses center - Tbilisi
- Worthwhile Clinical Trials - Benoni
- National Specialized Children's Hospital OKHMATDYT, Centre for Hemostatic Pathology (Ukraine) - Kyiv
- Institute of Blood Pathology and Transfusion Medicine - Lviv
Colorado
- University of Colorado Denver Hemophilia & Thrombosis Center - Aurora
Oklahoma
- Jimmy Everest Center for Cancer and Bleeding Disorders - Oklahoma City
Texas
- UT Southwestern Medical Center at Dallas / Children's Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2015-12-07 |
| Est. Completion | 2017-08-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02448680
The ClinicalTrials.gov registry entry for NCT02448680 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Laboratoire français de Fractionnement et de Biotechnologies, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Hemophilia A With Inhibitors appearing as the primary indexed condition, and to 1 intervention - of which Coagulation FVIIa (Recombinant) is the first listed.
NCT02448680 reports 9 study locations spanning 4 distinct geographic areas - top geographies include Other, Colorado, Oklahoma.
Frequently Asked Questions
What is clinical trial NCT02448680 about?
NCT02448680 is a clinical study titled "A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa". The purpose of the study is to assess the safety, efficacy and pharmacokinetics of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or IX in 12 patients ( birt...
What is the current status of trial NCT02448680?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 25 participants. The study started on 2015-12-07. Estimated completion is 2017-08-30.
What conditions does trial NCT02448680 study?
This clinical trial studies the following conditions: Hemophilia A With Inhibitors, Hemophilia B With Inhibitors.
What interventions are being tested in trial NCT02448680?
The interventions under investigation include: Coagulation FVIIa (Recombinant) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02448680?
This trial is sponsored by Laboratoire français de Fractionnement et de Biotechnologies, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02448680 being conducted?
This trial has 9 study locations across Colorado, Oklahoma, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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