- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01234545
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
November 13, 2014 updated by: Novo Nordisk A/S
A Prospective Observational Study on the Home Treatment of Haemarthrosis With rFVIIa (Activated Recombinant Factor VII) in Haemophilia A and B Patients With Inhibitors
This trial is conducted in Africa and Asia.
The aim of this study is to evaluate the efficacy of home treatment of joint bleeds (haemarthrosis) with NovoSeven® (activated recombinant human factor VII) in patients with haemophilia A and B patients with inhibitors.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
35
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
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Algiers, Algeria, 16035
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Casablanca, Morocco, 20000
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Muscat, Oman
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Riyadh, Saudi Arabia, 3542
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Dubai, United Arab Emirates
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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
2 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Patients with congenital haemophilia and inhibitors to Factor VIII or IX.
Description
Inclusion Criteria:
- Patients with congenital haemophilia and inhibitors to factor VIII or IX
- Indication of activated recombinant human factor VII for the treatment of joint bleeding located in elbow, shoulder, wrist, hip, knee, ankle
Exclusion Criteria:
- Known or suspected allergy to study product(s) or related products
- Clinically relevant coagulation disorders other than congenital haemophilia A or B
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 |
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A
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Prescription is done at the discretion of the prescribing physician as part of normal clinical routine
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Number of bleeds managed at home
Time Frame: Month 8
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Month 8
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Number of treatments resulting in the control of bleeding episode
Time Frame: within 9 hours after the first injection of study product
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within 9 hours after the first injection of study product
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Number of treatments resulting in effective pain relief
Time Frame: within 9 hours after the first injection of study product
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within 9 hours after the first injection of study product
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Proportion of patient/caregivers with no need of any intervention from the physician to treat the bleeding episode at home
Time Frame: Month 8
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Month 8
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Proportion of patients who used their entire treatment at home
Time Frame: Month 8
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Month 8
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
October 1, 2010
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
November 3, 2010
First Submitted That Met QC Criteria
November 3, 2010
First Posted (Estimate)
November 4, 2010
Study Record Updates
Last Update Posted (Estimate)
November 14, 2014
Last Update Submitted That Met QC Criteria
November 13, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F7HAEM-3850
- U1111-1116-2488 (Other Identifier: WHO)
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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Novo Nordisk A/SCompletedHealthy | Congenital Bleeding DisorderUnited States
Clinical Trials on activated recombinant human factor VII
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Novo Nordisk A/SCompletedTrauma | Acquired Bleeding DisorderUnited States, Canada
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Novo Nordisk A/SCompletedHealthy | Congenital Bleeding Disorder | Haemophilia A With Inhibitors | Haemophilia B With Inhibitors | Acquired Bleeding Disorder | Acquired Haemophilia | Congenital FVII Deficiency | Glanzmann's DiseaseFrance
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Novo Nordisk A/SCompletedAcquired Bleeding Disorder | Intracerebral HaemorrhageSpain, Sweden, Singapore, Norway, Italy, Switzerland, Australia, Austria, Belgium, Canada, Denmark, Finland, Germany, Netherlands, United Kingdom
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Novo Nordisk A/SCompletedHealthy | Congenital Bleeding DisorderUnited States
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Novo Nordisk A/SCompletedCongenital Bleeding Disorder | Haemophilia A | Haemophilia BFrance, Israel, Germany
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Novo Nordisk A/SCompletedOther Haemostasis Disorder | Haemorrhagic CystitisUnited States
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Novo Nordisk A/STerminatedAcquired Bleeding Disorder | Cardiac Surgery Requiring Cardiopulmonary BypassUnited States, Spain, Germany, Sweden, United Kingdom, Argentina, Italy, Brazil, Denmark, France, India, Malaysia, Singapore, South Africa
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Novo Nordisk A/SCompletedCongenital Bleeding Disorder | Haemophilia A With Inhibitors | Haemophilia B With InhibitorsFrance, United Kingdom, Spain, Israel, Poland, Turkey, Hungary
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Novo Nordisk A/SCompletedObservational Study on Safety and Efficacy of NovoSeven® in Subjects With Congenital FVII DeficiencyCongenital Bleeding Disorder | Congenital FVII DeficiencyJapan
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Novo Nordisk A/SCompletedCirrhosis | Acquired Bleeding DisorderGermany, United Kingdom, Spain, Taiwan, France, Italy, Austria, Czech Republic, Poland, Denmark, Finland, Hong Kong