Recombinant Factor VIIa: Local treament of severe bleedings after delivery

Recombinant Factor VIIa: Local treatment of severe postpartum hemorrhage - rFVIIa: Local treatment of PPH

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005036-20-DK

Enrollment

Unknown

Registered

2014-02-18

Start date

2014-02-18

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe postpartum bleeding MedDRA version: 16.1 Level: LLT Classification code 10071867 Term: Postpartum bleeding System Organ Class: 100000004868 MedDRA version: 16.1 Level: LLT Classification code 10071897 Term: Third stage postpartum bleeding System Organ Class: 100000004868

Interventions

Trade Name: NovoSevenRT Product Name: Recombinant Activated Factor VII Pharmaceutical Form: Powder and solution for solution for injection INN or Proposed INN: EPTACOG ALFA (ACTIVATED) CAS Number: 102

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with Placenta Previa Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients with allergy to NovoSeven RT or to mice; guinea pig or bovine proteins. Patients with coagulation disorders.

Design outcomes

Primary

Measure	Time frame
Main Objective: Through a pilot study involving 1-5 patients undergoing cesaren section for Placenta Previa to demonstrate hemostatic effect of recombinant FVIIa placed directly upon the placenta site;Secondary Objective: To study possible tromboembolic complications or adverse effects of the treatment;Primary end point(s): Visualisation of hemostatic effect. Time frome start treatment to hemostase, estimates of bleeding before and after treatment, measurements of coagulation parameters and hemoglobin before and after treatment, registration of all other treatments i.e. blood products, medicamina, mechanical and surgical treatment. Number of days spent in hospital/intensive care. ;Timepoint(s) of evaluation of this end point: Immediately within minutes	—

Measure

Time frame

Main Objective: Through a pilot study involving 1-5 patients undergoing cesaren section for Placenta Previa to demonstrate hemostatic effect of recombinant FVIIa placed directly upon the placenta site;Secondary Objective: To study possible tromboembolic complications or adverse effects of the treatment;Primary end point(s): Visualisation of hemostatic effect. Time frome start treatment to hemostase, estimates of bleeding before and after treatment, measurements of coagulation parameters and hemoglobin before and after treatment, registration of all other treatments i.e. blood products, medicamina, mechanical and surgical treatment. Number of days spent in hospital/intensive care. ;Timepoint(s) of evaluation of this end point: Immediately within minutes

—

Secondary

Measure	Time frame
Secondary end point(s): Tromboembolic complications or adverse effects;Timepoint(s) of evaluation of this end point: Within minutes to 24 hrs	—

Countries

Denmark

Contacts

Public ContactBirgit Schjoldager

Stellaris Pharmaceuticals ApS

birgit_lilienfeldt@hotmail.com33(0)618098858

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026