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Observational Patient Diary Study of Treatment Doses for Patients With Haemophilia With Inhibitors to Factors VIII and IX | Clinical Trials | Clareo Health

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Observational Patient Diary Study of Treatment Doses for Patients With Haemophilia With Inhibitors to Factors VIII and IX

Dosing Observational Study in Hemophilia Subjects With Inhibitors: A Phase IV Diary Study in Subjects Prescribed NovoSeven® as First Line on Demand Therapy for Acute Bleeding Episodes

NCT00710619•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

This study is conducted in the United States of America (USA). The aim of this study is to investigate the at-home-administration of bypassing agents for treatment of bleeding episodes in patients with congenital haemophilia with inhibitors to factors VIII and IX. We are further investigating how bleeding episodes affect the quality of life of the patient and their family or caregivers.

Eligibility

Age

All ages

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Male subjects with congenital haemophilia A or B and inhibitors with spontaneous bleeds which require on-demand treatment
•Subjects prescribed NovoSeven® as the first line or recommended bypass agent
•History of on average at least 4 bleeds of any type over a 3 month period
•Subject or caregiver able and willing to complete daily journal for 3 months
•Informed consent obtained from all subjects or legal representative

Locations (1)

Novo Nordisk Investigational Site

Plainsboro, New Jersey, United States

Key Dates

Start Date

June 1, 2008

Primary Completion Date

July 1, 2009

Completion Date

July 1, 2009

Last Updated

November 17, 2016

Enrollment

ACTUAL participants

Conditions

Congenital Bleeding DisorderHaemophilia A With InhibitorsHaemophilia B With Inhibitors

Interventions

activated recombinant human factor VII

DRUG

Feiba VH

DRUG

Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A

NCT02137850

Congenital Bleeding DisorderHaemophilia A

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COMPLETEDPHASE3

Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B

NCT02141074

Congenital Bleeding DisorderHaemophilia B

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 17, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Observational Patient Diary Study of Treatment Doses for Patients With Haemophilia With Inhibitors to Factors VIII and IX

Inclusion Criteria

Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A

Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B

A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B

Study Investigating Novoeight®/NovoEight® (Turoctocog Alfa) in Mexican Haemophilia A Patients

Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A

Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With Inhibitors