Congenital Bleeding DisorderNCT01988532
Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia
An observational study of Congenital Bleeding Disorder and Haemophilia A, 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 the study is to assess the impact of pain on functional impairment and quality of life in adult persons with hemophilia (PWH) with and without inhibitors with joint bleeding. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia A With Inhibitors
- What is being tested?
- No treatment given
- How many people
- 381 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Oct 2014
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive adult PWH in the United States of America (USA) willing to consent to participation who have any history of joint bleeding or joint pain presenting for a comprehensive care visit during which joint range of motion will be assessed.
Who may be able to join
- Adult males able to provide consent and complete a survey in English
- Congenital hemophilia A or B with or without inhibitors with any history of joint bleeding or joint pain
- Presentation at the treatment center for a comprehensive annual visit where joint range of motion will be obtained
- Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol)
Who cannot join
- Previous participation in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Novo Nordisk Investigational Site
Plainsboro, New Jersey, 08536
About this study
This study is conducted in the United States of America (USA). The aim of the study is to assess the impact of pain on functional impairment and quality of life in adult persons with hemophilia (PWH) with and without inhibitors with joint bleeding.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia A With Inhibitors, Haemophilia B, Haemophilia B With Inhibitors
- Being tested
- No treatment given
- Medical subject headings
- Hemophilia A, Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
Subject will only fill out a questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Adult PWH | Not described Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of acute (bleed-related) pain (percentage)
Measured: At the first visit (only one study visit)
Prevalence of chronic (arthritic) pain (percentage)
Measured: At the first visit (only one study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Cross-sectional
- Enrolment
- 381 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
- NCT01988532
- Sponsor's protocol ID
- HAEM-4073
- Other IDs
- U1111-1138-3464
- Status last verified
- Jan 2017
- First submitted
- 17 Oct 2013
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang M., Baumann K., Akins S., Funk S., Hernandez G., Kempton C., Buckner T., Cooper D. Pain, Functional Impairment, and Quality of Life (P-FIQ): Reliability of Patient-Reported Outcome (PRO) Instruments Assessing Pain and Function in US Adult People With Hemophilia (PWH). 14th WFH International Musculoskeletal Congress 2015; : Abstract number: P-224 Country: Northern Ireland City: Belfast
Baumann K., Akins S., Funk S., Hernandez G., Kempton C., Wang M., Buckner T., Cooper D. Functional Impairment, Pain, and Pain Management in Adult People with Haemophilia (PWH): Initial Lessons from the Pain Functional Impairment and Quality of Life (P-FIQ) Study. 14th WFH International Musculoskeletal Congress 2015; : Abstract number: MP-209 Country: Northen Ireland City: Belfast
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia
- ClinicalTrials.gov ID
- NCT01988532
- Acronym / sponsor ID
- HAEM-4073
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia A With Inhibitors, Haemophilia B, Haemophilia B With Inhibitors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 Nov 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 the study is to assess the impact of pain on functional impairment and quality of life in adult persons with hemophilia (PWH) with and without inhibitors with joint bleeding.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult PWH | – | Other: No treatment given |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive adult PWH in the United States of America (USA) willing to consent to participation who have any history of joint bleeding or joint pain presenting for a comprehensive care visit during which joint range of motion will be assessed.
Key inclusion criteria (4 listed)
- Adult males able to provide consent and complete a survey in English
- Congenital hemophilia A or B with or without inhibitors with any history of joint bleeding or joint pain
- Presentation at the treatment center for a comprehensive annual visit where joint range of motion will be obtained
- Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol)
Key exclusion criteria (1 listed)
- Previous participation in this study
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 |
|---|---|---|
| No treatment givenSubject will only fill out a questionnaire | Other | Adult PWH |
Primary outcome
Prevalence of acute (bleed-related) pain (percentage)
Time frame: At the first visit (only one study visit)
Prevalence of chronic (arthritic) pain (percentage)
Time frame: At the first visit (only one study visit)
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 18 Jan 2017.
- Results publicationWang M., Baumann K., Akins S., Funk S., Hernandez G., Kempton C., Buckner T., Cooper D. Pain, Functional Impairment, and Quality of Life (P-FIQ): Reliability of Patient-Reported Outcome (PRO) Instruments Assessing Pain and Function in US Adult People With Hemophilia (PWH). 14th WFH International Musculoskeletal Congress 2015; : Abstract number: P-224 Country: Northern Ireland City: Belfast
- Results publicationBaumann K., Akins S., Funk S., Hernandez G., Kempton C., Wang M., Buckner T., Cooper D. Functional Impairment, Pain, and Pain Management in Adult People with Haemophilia (PWH): Initial Lessons from the Pain Functional Impairment and Quality of Life (P-FIQ) Study. 14th WFH International Musculoskeletal Congress 2015; : Abstract number: MP-209 Country: Northen Ireland City: Belfast
- 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, 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 4 inclusion and 1 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 18 Jan 2017. 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?
Prevalence of acute (bleed-related) pain (percentage) (time frame: At the first visit (only one study visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01988532, which also lists 2 linked publications.
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 18 Jan 2017.