Haemophilia ATHIRdNCT04584892
Turoctocog Alfa in Haemophilic Italian Patients: Protection and Engagement in Recreational Activities
An observational study of Haemophilia A, run by Novo Nordisk A/S at 10 sites in Italy.
Trial summary
This is a study on Italian patients with haemophilia A in prophylaxis treatment with Turoctocog alfa under routine clinical conditions. The purpose of the study is to investigate the therapeutic scheme in a population of patients treated with Turoctocog alfa and to investigate the participation in recreational… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Haemophilia A
- What is being tested?
- Turoctocog alfa
- How many people
- 18 participants
- Where
- 10 sitesItaly
- Study dates
- 12 Apr 2021to 27 Mar 2023
- 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 12 years and older
- All sexes
- Child, Adult, Older adult
Study population: Patients enrolled will have Haemophilia A (any severity), needing turoctocog alpha prophylactic therapy.
Who may be able to join
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Male or female, age above or equal to 12 years at the time of signing informed consent.
- Haemophilia A (any severity), needing prophylactic therapy (with the usual recommended doses).
- Decision to treat with turoctocog alfa, made by the treating Physician and the subject/Legally Acceptable Representative (LAR) based on local label before and independently from the decision to include the subject in this study.
Who cannot join
- Previous participation in this study, defined as previously signed informed consent;
- Presence of other coagulation disorders;
- Presence of any inhibitor;
- Mental problems, poor compliance, linguistic barriers or other conditions which can impede the understanding of the study aims and the participation to it.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Italy10 sites
Novo Nordisk Investigational Site
Bologna, 40138
Novo Nordisk Investigational Site
Castelfranco Veneto, 31033
Novo Nordisk Investigational Site
Catania, 95123
Novo Nordisk Investigational Site
Cesena, 47521
Novo Nordisk Investigational Site
Florence, 50134
Novo Nordisk Investigational Site
Milan, MI, 20124
Novo Nordisk Investigational Site
Milan, 20089
Novo Nordisk Investigational Site
Naples, 80147
Novo Nordisk Investigational Site
Roma, 00161
Novo Nordisk Investigational Site
Vicenza, 36100
About this study
Official title: Turoctocog Alfa in Haemophilic Italian Patients: Protection and Engagement in Recreational Activities (THIRd). An Observational, Prospective, Multicentre, Cohort Study on Italian Patients With Haemophilia A in Prophylaxis Treatment With Turoctocog Alfa Under Current Clinical Conditions
This is a study on Italian patients with haemophilia A in prophylaxis treatment with Turoctocog alfa under routine clinical conditions. The purpose of the study is to investigate the therapeutic scheme in a population of patients treated with Turoctocog alfa and to investigate the participation in recreational activities, the level of physical activity, and quality of life. Participants will get NovoEight® (Turoctocog alfa) as prescribed to them by the study doctor. The study will last for about 12 months. Participants will be requested to fill in the Questionnaires investigating the participation in recreational activities, the level of physical activity, and quality of life.
- Conditions
- Haemophilia A
- Being tested
- Turoctocog alfa
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turoctocog alfaDrug
Patients will be treated with commercially available NovoEight® (turoctocog alfa) according to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available NovoEight® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
| Study group | Role | What they receive |
|---|---|---|
| Haemophilia A | Patients enrolled will have Haemophilia A (any severity), needing turoctocog alpha prophylactic therapy. Receives: Drug: Turoctocog alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual prophylaxis (PPX) regimen with turoctocog alfa: Every second day, or three times a week (3TW), or twice a week (2TW)
Count
Measured: Baseline (week 0)
Secondary outcomes (6)
Individual PPX regimen with turoctocog alfa: every second day, or 3TW, or 2TW
Count
Measured: Final visit (12 months)
Change of PPX regimen: YES/NO
Count (participants who have changed regimen or not)
Measured: 12 months after treatment initiation
Reported reasons for change of PPX regimens
Count (reasons according to the predefined list, see below)
Individual reported reasons for switch will be selected among the following predefined:
- to improve articular protection
- due to bleedings
- due to patients' needs, including: physical inactivity, work, recreational activity, travel, other.
Measured: Final visit (12 months)
Difference in score of 'Bridging Hemophilia Experiences, Results, and Opportunities' BHERO questionnaire
Points
The following sections of the BHERO questionnaire will be used:
- Haemophilia Activities List (HAL: measures the impact of haemophilia on self-perceived functional abilities in patients (42 questions in 7 domains). Scores from 1 (worst) to 6 (best). The final score is the sum of all the scores.)
- Recreational and sport activities
- Brief pain inventory, exploring the presence and intensity of physical pain, and its impact on performance of daily activities.
- International Physical Activities questionnaire (IPAQ) score (Score<700 = Inactive Patient, Score 700 to 2519 = Sufficiently active patient, Score ≥ 2520 = Active or very active patient.
Measured: Final visit (12 months) vs Baseline (week 0)
Difference in circulating turoctocog alfa levels
IU/mL
Before 12 months visit, monitoring will be reported only if measured in clinical practice due to bleedings or other clinical reasons.
Measured: Final visit (12 months) vs Baseline (week 0)
Individual Annual Bleeding Rate (ABR)
Count
Measured: From baseline to final visit (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start12 Apr 2021
- Primary completion27 Mar 2023
- Study completion27 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemophilia AStudies 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
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure 1452, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584892
- Sponsor's protocol ID
- NN7008-4655
- Other IDs
- U1111-1247-5494
- Acronym
- THIRd
- Status last verified
- Nov 2023
- First submitted
- 6 Oct 2020
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turoctocog Alfa in Haemophilic Italian Patients: Protection and Engagement in Recreational Activities (THIRd). An Observational, Prospective, Multicentre, Cohort Study on Italian Patients With Haemophilia A in Prophylaxis Treatment With Turoctocog Alfa Under Current Clinical Conditions
- ClinicalTrials.gov ID
- NCT04584892
- Acronym / sponsor ID
- THIRd / NN7008-4655
- Conditions
- Haemophilia A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 27 Mar 2023 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 14 Oct 2020 (actual)
- 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 is a study on Italian patients with haemophilia A in prophylaxis treatment with Turoctocog alfa under routine clinical conditions. The purpose of the study is to investigate the therapeutic scheme in a population of patients treated with Turoctocog alfa and to investigate the participation in recreational activities, the level of physical activity, and quality of life. Participants will get NovoEight® (Turoctocog alfa) as prescribed to them by the study doctor. The study will last for about 12 months. Participants will be requested to fill in the Questionnaires investigating the participation in recreational activities, the level of physical activity, and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Haemophilia A | – | Drug: Turoctocog alfaPatients enrolled will have Haemophilia A (any severity), needing turoctocog alpha prophylactic therapy. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients enrolled will have Haemophilia A (any severity), needing turoctocog alpha prophylactic therapy.
Key inclusion criteria (4 listed)
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Male or female, age above or equal to 12 years at the time of signing informed consent.
- Haemophilia A (any severity), needing prophylactic therapy (with the usual recommended doses).
- Decision to treat with turoctocog alfa, made by the treating Physician and the subject/Legally Acceptable Representative (LAR) based on local label before and independently from the decision to include the subject in this study.
Key exclusion criteria (4 listed)
- Previous participation in this study, defined as previously signed informed consent;
- Presence of other coagulation disorders;
- Presence of any inhibitor;
- Mental problems, poor compliance, linguistic barriers or other conditions which can impede the understanding of the study aims and the participation to it.
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 |
|---|---|---|
| Turoctocog alfaPatients will be treated with commercially available NovoEight® (turoctocog alfa) according to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available NovoEight® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study. | Drug | Haemophilia A |
Primary outcome
Individual prophylaxis (PPX) regimen with turoctocog alfa: Every second day, or three times a week (3TW), or twice a week (2TW)
Time frame: Baseline (week 0)
Count
6 secondary outcomes
Individual PPX regimen with turoctocog alfa: every second day, or 3TW, or 2TW
Time frame: Final visit (12 months)
Change of PPX regimen: YES/NO
Time frame: 12 months after treatment initiation
Reported reasons for change of PPX regimens
Time frame: Final visit (12 months)
Difference in score of 'Bridging Hemophilia Experiences, Results, and Opportunities' BHERO questionnaire
Time frame: Final visit (12 months) vs Baseline (week 0)
Difference in circulating turoctocog alfa levels
Time frame: Final visit (12 months) vs Baseline (week 0)
Individual Annual Bleeding Rate (ABR)
Time frame: From baseline to final visit (12 months)
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 28 Nov 2023.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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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.
Clinical Reporting Anchor and Disclosure 1452 study director
Novo Nordisk A/S
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemophilia A, run by Novo Nordisk A/S at 10 sites in Italy.
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 4 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 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy. 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?
Individual prophylaxis (PPX) regimen with turoctocog alfa: Every second day, or three times a week (3TW), or twice a week (2TW) (time frame: Baseline (week 0)). 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 28 Nov 2023.