CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 12 enrolled
Drug / intervention
Coagulation Factor VIIa (Recombinant)biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02548143
NCT02548143Phase 3Completed

Phase 3 Study of Safety and Efficacy of Coagulation Factor VIIa (Recombinant) for Prevention of Excessive Bleeding in Congenital Hemophilia A/B Patients With Inhibitors to Factor VIII/IX Undergoing Elective Surgery/Other Invasive Procedures

Laboratoire français de Fractionnement et de Biotechnologies·interventional·Posted Sep 14, 2015·Updated Feb 25, 2022

In Brief

A Phase 3 clinical trial evaluating Coagulation Factor VIIa (Recombinant) for Hemophilia. Completed, enrolled 12 participants across 9 sites in 6 countries.

Detailed Summary

The purpose of this study, PerSept 3, is to evaluate LR769 for the prevention of excessive bleeding and achievement of hemostasis in congenital hemophilia A or B patients who have inhibitors to Factor VIII or Factor IX , are aged 6 months to 75 years, inclusive; and who are undergoing elective surgical or other invasive procedures. Administration of LR769 will be performed just prior to surgery/procedure and will be repeated during and after the surgery/procedure to achieve and maintain adequate hemostasis as determined by the investigator's judgment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia
CountriesMexico, Russia, South Africa, Spain, Ukraine, United States
CollaboratorsLFB USA, Inc.

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 14, 2015
Enrollment StartAug 25, 2016
Primary CompletionAug 6, 2017
Study CompletionAug 31, 2017
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 10.8 years ago

Interventions

Coagulation Factor VIIa (Recombinant)biological

LR769