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A Long-term Assessment of Physical Activity, Range of Motion, and Functional Status Following Elective Orthopedic Surgery in Hemophilia Patients With Inhibitors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01830712
First Posted: April 12, 2013
Last Update Posted: April 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This study is conducted in the United States of America (USA). The aim of this study is to assess the long-term (5+ years) postoperative functional outcomes of elective orthopaedic surgery (EOS) patients from previously reported studies F7HAEM/USA/3/USA and F7HAEM/USA/4/USA (NCT01561391) and furthermore to assess the impact of EOS on psychosocial outcomes, frequency of bleeding episodes and durability of joint surgery.

Condition Intervention
Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors Drug: eptacog alfa (activated)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Long-Term Assessment of Physical Activity, Range of Motion, and Functional Status Following Elective Orthopedic Surgery in Hemophilia Patients With Inhibitors. A Retrospective Follow-up Assessment to F7HAEM/USA/3/USA and F7HAEM/USA/4/USA

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Long-term changes in general mobility/ambulation/activity [ Time Frame: From pre-operative (baseline) functional status and up to at least 5 years ]

Secondary Outcome Measures:
  • Long-term changes in work/school attendance [ Time Frame: From pre-operative (baseline) functional status and up to at least 5 years ]
  • Long-term changes in employment status [ Time Frame: From pre-operative (baseline) functional status and up to at least 5 years ]
  • Long-term changes in body mass index (BMI) [ Time Frame: From pre-operative (baseline) functional status and up to at least 5 years ]
  • Long-term changes in complications related to surgical procedure and/or prostheses [ Time Frame: From pre-operative (baseline) functional status and up to at least 5 years ]
  • Overall frequency of bleeding episodes [ Time Frame: From pre-operative (baseline) functional status and up to at least 5 years ]
  • Number of joint infections [ Time Frame: From pre-operative (baseline) functional status and up to at least 5 years ]
  • Number of treatment types (on demand, prophylaxis) [ Time Frame: From pre-operative (baseline) functional status and up to at least 5 years ]

Enrollment: 15
Study Start Date: April 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Chart review Drug: eptacog alfa (activated)
A review of retrospectively longitudinal data gathered in the routine follow-up from a subset of patients who underwent EOS in studies F7HAEM/USA/3/USA and F7HAEM/USA/4/USA (NCT01561391). Data will be compiled, analysed, and reported in aggregate form.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Haemophilia patients with inhibitors who had EOS during their participation in F7HAEM/USA/3/USA or F7HAEM/USA/4/USA (NCT01561391).
Criteria

Inclusion Criteria:

  • Haemophilia patients with inhibitors who have had EOS during their participation in F7HAEM/USA/3/USA and F7HAEM/USA/4/USA (NCT01561391)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01830712


Locations
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01830712     History of Changes
Other Study ID Numbers: F7HAEM-3864
U1111-1114-9206 ( Other Identifier: WHO )
First Submitted: April 10, 2013
First Posted: April 12, 2013
Last Update Posted: April 15, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Vascular Diseases
Cardiovascular Diseases