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Completed

NCT Number: NCT00710619

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

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.

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Key information

Conditions

Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors

Sex eligibility

Male

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Plainsboro, New Jersey, 08536, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

activated recombinant human factor VII

Drug

This is an observation of how patients/caregivers dose bypassing agents at home for haemophilia with inhibitors

Feiba VH

Drug

This is an observation of how patients/caregivers dose bypassing agents at home for hemophilia with inhibitors

Primary outcomes

  1. Characterisation of dose and dosing intervals for each bleeding episode

    Time frame: after 3-6 months

Secondary outcomes

  1. Effect of type of bleed on initial dose, dosing interval and total dose

    Time frame: after 3-6 months

  2. Effect of initial dose and dosing interval on total dose, time to first perceived improvement, time to perceived bleed resolution

    Time frame: after 3-6 months

  3. Effect of time to first dose on dosing interval and total dose

    Time frame: after 3-6 months

  4. Effect of bleeds and drug administration time on planned daily activities

    Time frame: after 3-6 months

  5. Relationship of dose and dosing intervals to reported SAEs

    Time frame: after 3-6 months

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Acronym: DOSE

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 4, 2008
Registry last updated
Nov 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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