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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00710619
Other study ID # F7HAEM-1965
Secondary ID
Status Completed
Phase N/A
First received July 3, 2008
Last updated November 16, 2016
Start date June 2008
Est. completion date July 2009

Study information

Verified date November 2016
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective


Intervention

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

Locations

Country Name City State
United States Novo Nordisk Investigational Site Plainsboro New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Characterisation of dose and dosing intervals for each bleeding episode after 3-6 months No
Secondary Effect of type of bleed on initial dose, dosing interval and total dose after 3-6 months No
Secondary Effect of initial dose and dosing interval on total dose, time to first perceived improvement, time to perceived bleed resolution after 3-6 months No
Secondary Effect of time to first dose on dosing interval and total dose after 3-6 months No
Secondary Effect of bleeds and drug administration time on planned daily activities after 3-6 months No
Secondary Relationship of dose and dosing intervals to reported SAEs after 3-6 months No
See also
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