Safety and Efficacy of Activated Recombinant Human Factor VII in Haemophilia Patients With Inhibitors During and After Major Surgery

ClinicalTrials.gov ID: NCT01561391

Public ClinicalTrials.gov record NCT01561391. 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.

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Official title

An Open-Label, Randomized, Parallel, Multicenter Trial Comparing the Safety and Efficacy of rFVIIa When Administered as i.v. Bolus or i.v. Continuous Infusion to Hemophiliacs With Inhibitors During and After Major Surgery

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This trial is conducted in North America. The aim of this trial is to compare the safety and efficacy of activated recombinant human factor VII in patients with haemophilia A or B undergoing major surgical procedures.

Study identification

NCT ID: NCT01561391
Recruitment status: Completed
Study type: Interventional
Phase: Phase 4
Lead sponsor: Novo Nordisk A/S; Industry
Enrollment: 36 participants

Conditions and interventions

Conditions

Interventions

activated recombinant human factor VII Drug
factor IX Other
factor VIII Drug

Drug · Other

Eligibility (public fields only)

Age range: 5 Years and older
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: Apr 1998 (Type not available)
Primary completion: May 2004 (Actual)
Completion: May 2004 (Actual)
Last update posted: Dec 29, 2023

1998 – 2004

United States locations

U.S. sites: 14
U.S. states: 11
U.S. cities: 12

Facility	City	State	ZIP	Site status
Novo Nordisk Investigational Site	Los Angeles	California	90027	—
Novo Nordisk Investigational Site	Chicago	Illinois	60611	—
Novo Nordisk Investigational Site	Chicago	Illinois	60612	—
Novo Nordisk Investigational Site	New Orleans	Louisiana	70112	—
Novo Nordisk Investigational Site	Boston	Massachusetts	02115	—
Novo Nordisk Investigational Site	Rochester	Minnesota	55905	—
Novo Nordisk Investigational Site	New Brunswick	New Jersey	08903	—
Novo Nordisk Investigational Site	Albuquerque	New Mexico	87106	—
Novo Nordisk Investigational Site	New York	New York	10029-6574	—
Novo Nordisk Investigational Site	Chapel Hill	North Carolina	27599-7220	—
Novo Nordisk Investigational Site	Hershey	Pennsylvania	17033	—
Novo Nordisk Investigational Site	Philadelphia	Pennsylvania	19104	—
Novo Nordisk Investigational Site	Philadelphia	Pennsylvania	19107	—
Novo Nordisk Investigational Site	Houston	Texas	77030	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01561391, 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 Dec 29, 2023 · Synced Oct 21, 2026

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The complete public registry record, listed eligibility criteria, and available contact information for NCT01561391 live on ClinicalTrials.gov.

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