MedDataX Logo

Non-Interventional Study of NovoSeven® Used in Patients With Haemophilia A and B With Inhibitors When Undergoing Surgery

NCT ID: NCT01579968

Last Updated: 2017-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-03-10

Study Completion Date

2010-03-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is conducted in Japan. The aim of this non-interventional study is to investigate the safety and effectiveness of treatment with eptacog alpha (NovoSeven®) when undergoing surgery under normal clinical practice conditions.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Non-Interventional Study of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors

NCT01586936

Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors
COMPLETED

Non-Interventional Study of NovoSeven® Used in Patients With Haemophilia A and B With Inhibitors Under Normal Clinical Practice

NCT01579955

Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors
COMPLETED

Trial of NovoSeven® in Haemophilia - Joint Bleeds

NCT00108797

Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors
COMPLETED PHASE4

To Investigate Safety and Efficacy of NovoEight® (rFVIII) During Long-term Treatment of Haemophilia A in Japan

NCT02207218

Congenital Bleeding Disorder Haemophilia A
COMPLETED

Observational Registry of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors

NCT00703911

Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors
COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

eptacog alpha users

eptacog alfa (activated)

Intervention Type DRUG

Safety and effectiveness data collection in connection with the use of eptacog alpha in daily clinical practice

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

eptacog alfa (activated)

Safety and effectiveness data collection in connection with the use of eptacog alpha in daily clinical practice

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with haemophilia A and B with inhibitors who received eptacog alpha (NovoSeven®) as treatment when undergoing surgery

Exclusion Criteria

* Patients who was not deemed to be appropriate to the treatment of eptacog alpha (NovoSeven®)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novo Nordisk Investigational Site

Tokyo, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Related Links

Access external resources that provide additional context or updates about the study.

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

F7-1948

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Observational Study on Safety and Efficacy of NovoSeven® in Subjects With Congenital FVII Deficiency
NCT01312636 COMPLETED
Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors
NCT01234545 COMPLETED
Observational Study on the Efficacy and Safety of NovoSeven® During "Real-life" Usage in Germany
NCT00697320 COMPLETED
Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery
NCT05936580 RECRUITING PHASE4
Safety and Efficacy of Activated Recombinant Human Factor VII in Haemophilia Patients With Inhibitors During and After Major Surgery
NCT01561391 COMPLETED PHASE4
Evaluating the Haemostatic Effect of NNC 0129-0000-1003 During Surgical Procedures in Subjects With Haemophilia A.
NCT01489111 COMPLETED PHASE3
Haemophilia Patients With Inhibitors Being Treated for Acute Joint Bleeds
NCT00486278 COMPLETED PHASE2
Prediction of the Efficacy of Activated Recombinant Human Factor VII in Adult Congenital Haemophilia A or B Patients With Inhibitors by Use of Thromboelastography
NCT01561924 COMPLETED PHASE1
Observational Study on the Use of NovoSeven® for Haemostatic Treatment of Bleeding Episodes in Patients With Acquired Haemophilia
NCT01285089 COMPLETED
Investigating the Bioequivalence of Eptacog Alfa A 6 mg and NovoSeven® in Healthy Male Subjects
NCT02084810 WITHDRAWN PHASE1
Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia
NCT00108758 COMPLETED PHASE2
Evaluation of Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Subjects With Haemophilia A
NCT01480180 COMPLETED PHASE3
Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015
NCT00984126 COMPLETED PHASE3
Evaluation of Recombinant Factor VIIa in Patients With Severe Bleeding
NCT00184548 TERMINATED PHASE3
Safety, Tolerability, and Pharmacokinetics Study of Turoctocog Alfa Pegol Injected Under the Skin in Patients With Haemophilia A
NCT02994407 COMPLETED PHASE1
Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII in Acute Intracerebral Haemorrhage
NCT01566786 COMPLETED PHASE2
A Study of TAK-660 in Surgical Procedures for People With Hemophilia A.
NCT04941898 COMPLETED
Study of Recombinant Human Coagulation Factor VIIa for Injection (FⅦa) in Patients With Hemophilia.
NCT04768699 UNKNOWN PHASE1
Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B
NCT02141074 COMPLETED PHASE3
Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A
NCT01493778 COMPLETED PHASE3
Recombinant Factor VIIa in Acute Intracerebral Haemorrhage
NCT00127283 COMPLETED PHASE3
A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors
NCT01949792 COMPLETED PHASE1
Observational Patient Diary Study of Treatment Doses for Patients With Haemophilia With Inhibitors to Factors VIII and IX
NCT00710619 COMPLETED
Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects
NCT00840086 COMPLETED PHASE3
A Phase 3 Study of the Safety and Efficacy of Coagulation Factor VIIa (Recombinant) for the Prevention of Excessive Bleeding in Patients With Congenital Hemophilia A or B With Inhibitors to Factor VIII or IX Undergoing Elective Major Surgical Procedures SCOPE HIM
NCT05695391 TERMINATED PHASE3