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

November 16, 2016 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Plainsboro, New Jersey, United States, 08536
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Male subjects with congenital haemophilia A or B with inhibitors with spontaneous bleeds requiring on-demand treatment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Drug: activated recombinant human factor VII
This is an observation of how patients/caregivers dose bypassing agents at home for haemophilia with inhibitors
Drug: Feiba VH
This is an observation of how patients/caregivers dose bypassing agents at home for hemophilia with inhibitors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Characterisation of dose and dosing intervals for each bleeding episode
Time Frame: after 3-6 months
after 3-6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect of type of bleed on initial dose, dosing interval and total dose
Time Frame: after 3-6 months
after 3-6 months
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
after 3-6 months
Effect of time to first dose on dosing interval and total dose
Time Frame: after 3-6 months
after 3-6 months
Effect of bleeds and drug administration time on planned daily activities
Time Frame: after 3-6 months
after 3-6 months
Relationship of dose and dosing intervals to reported SAEs
Time Frame: after 3-6 months
after 3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

July 3, 2008

First Submitted That Met QC Criteria

July 3, 2008

First Posted (Estimate)

July 4, 2008

Study Record Updates

Last Update Posted (Estimate)

November 17, 2016

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F7HAEM-1965

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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