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:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01830712
First received: April 10, 2013
Last updated: April 14, 2014
Last verified: April 2014
  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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Long-term changes in employment status [ Time Frame: From pre-operative (baseline) functional status and up to at least 5 years ] [ Designated as safety issue: No ]
  • Long-term changes in body mass index (BMI) [ Time Frame: From pre-operative (baseline) functional status and up to at least 5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Overall frequency of bleeding episodes [ Time Frame: From pre-operative (baseline) functional status and up to at least 5 years ] [ Designated as safety issue: No ]
  • Number of joint infections [ Time Frame: From pre-operative (baseline) functional status and up to at least 5 years ] [ Designated as safety issue: No ]
  • Number of treatment types (on demand, prophylaxis) [ Time Frame: From pre-operative (baseline) functional status and up to at least 5 years ] [ Designated as safety issue: No ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01830712     History of Changes
Other Study ID Numbers: F7HAEM-3864, U1111-1114-9206
Study First Received: April 10, 2013
Last Updated: April 14, 2014
Health Authority: United States: Institutional Review Board

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
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014