Congenital Bleeding DisorderNCT01830712
A Long-term Assessment of Physical Activity, Range of Motion, and Functional Status Following Elective Orthopedic Surgery in Hemophilia Patients With Inhibitors
An observational study of Congenital Bleeding Disorder and Haemophilia A With Inhibitors, run by Novo Nordisk A/S at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- What is being tested?
- eptacog alfa (activated)
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Haemophilia patients with inhibitors who had EOS during their participation in F7HAEM/USA/3/USA or F7HAEM/USA/4/USA (NCT01561391).
Who may be able to join
- Haemophilia patients with inhibitors who have had EOS during their participation in F7HAEM/USA/3/USA and F7HAEM/USA/4/USA (NCT01561391)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novo Nordisk Clinical Trial Call Center
Princeton, New Jersey, 08540
About this study
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
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.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Being tested
- eptacog alfa (activated)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eptacog alfa (activated)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Chart review | Not described Receives: Drug: eptacog alfa (activated) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term changes in general mobility/ambulation/activity
Measured: From pre-operative (baseline) functional status and up to at least 5 years
Secondary outcomes (7)
Long-term changes in work/school attendance
Measured: From pre-operative (baseline) functional status and up to at least 5 years
Long-term changes in employment status
Measured: From pre-operative (baseline) functional status and up to at least 5 years
Long-term changes in body mass index (BMI)
Measured: 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
Measured: From pre-operative (baseline) functional status and up to at least 5 years
Overall frequency of bleeding episodes
Measured: From pre-operative (baseline) functional status and up to at least 5 years
Number of joint infections
Measured: From pre-operative (baseline) functional status and up to at least 5 years
Number of treatment types (on demand, prophylaxis)
Measured: From pre-operative (baseline) functional status and up to at least 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startApr 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Bleeding DisorderStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830712
- Sponsor's protocol ID
- F7HAEM-3864
- Other IDs
- U1111-1114-9206
- Status last verified
- Dec 2023
- First submitted
- 10 Apr 2013
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01830712
- Acronym / sponsor ID
- F7HAEM-3864
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 12 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chart review | – | Drug: eptacog alfa (activated) |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Haemophilia patients with inhibitors who had EOS during their participation in F7HAEM/USA/3/USA or F7HAEM/USA/4/USA (NCT01561391).
Key inclusion criteria (1 listed)
- Haemophilia patients with inhibitors who have had EOS during their participation in F7HAEM/USA/3/USA and F7HAEM/USA/4/USA (NCT01561391)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Chart review |
Primary outcome
Long-term changes in general mobility/ambulation/activity
Time frame: From pre-operative (baseline) functional status and up to at least 5 years
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Bleeding Disorder and Haemophilia A With Inhibitors, run by Novo Nordisk A/S at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term changes in general mobility/ambulation/activity (time frame: From pre-operative (baseline) functional status and up to at least 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.