HemophiliaEPOCHNCT07454239
EPOCH-Economics and Patient Outcomes in China in Haemophilia
An observational study of Hemophilia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
The overarching goal of the EPOCH project is to: Support a broad and robust needs assessment in the haemophilia space in China Measure the variability in the needs and care provision Generate outcome data (health economic outcomes and supporting clinical and PRO data) to enable measuring the impact of different… Read more about this study
- Who is it for?
- Ages 12 minutes and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hemophilia
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 14 Nov 2024to 31 Dec 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 minutes and older
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Male patients, aged ≥12 years at the index date
Who may be able to join
- Male patients, aged ≥12 years at the index date
- Patients must be diagnosed with non-acquired severe haemophilia A or B prior to the previous 12 months
- Patients who are able to understand and assent / consent to the study
Who cannot join
- Patients who cannot, for any reasons (language barriers, mental incapacity, etc.) understand and answer the questions of the study questionnaires
- Patients that cannot access internet connection or download the application
Trial locations and contacts
1 site in 1 country.
China1 site
Instiute of Hematology and Blood Diseases Hospital CAMS＆PUMC
Tianjin, Tianjin Municipality, 300020
About this study
The overarching goal of the EPOCH project is to:
- Support a broad and robust needs assessment in the haemophilia space in China
- Measure the variability in the needs and care provision
- Generate outcome data (health economic outcomes and supporting clinical and PRO data) to enable measuring the impact of different treatment modalities and different levels of treatment access PRIMARY OBJECTIVES
- Determine the burden of haemophilia in China, and the determinants of its variability
- Determine the costs of haemophilia care in China, and the determinants of its variability SECONDARY OBJECTIVES
- Measure treatment patterns and their variability
- Measure levels of access to care
- Estimate the impact of haemophilia and its treatment of patients reported outcomes
- Understand consistency of care by centres/geography/demographics
- Conditions
- Hemophilia
- Medical subject headings
- Hemophilia A
What is being measured
The primary outcome is the main question the study is designed to answer.
Successfully registered research centers
Successfully registered research centers in Trial Phase
Measured: Baseline until week 52
Number of enrolled patients
Number of enrolled patients in Trial Phase
Measured: Baseline until week 52
Proportion of completed questionnaires
Proportion of completed questionnaires for the Trial Phase
Measured: Baseline until week 52
Proportion of missing data
Proportion of missing data for the Trial Phase
Measured: Baseline until week 52
Qualitative information on study barriers and facilitators
Qualitative information on study barriers and facilitators for the Trial Phase
Measured: Baseline until week 52
Diagnostic and treatment burden for hemophilia patients
Diagnostic and treatment burden for hemophilia patients for the Implementation Phase
Measured: Baseline until week 52
Costs of hemophilia diagnosis and treatment
Costs of hemophilia diagnosis and treatment for the Implementation Phase
Measured: Baseline until week 52
Secondary outcomes (3)
Measure treatment patterns and their variability
Measures of treatment patterns will be defined by type of treatment product, dose and frequency of administration. These measures will be considered in relation to severity of disease and eventually presence of inhibitors and relevant comorbidities.
This measure will be collected both cross-sectionally and prospectively and reported directly by the patients.
By organizing patient-level data and applying statistical analysis methods, we calculated the total cost of hemophilia diagnosis and treatment in China and specific regions.
Measured: Baseline until week 52
Measure levels of access to care
The access to care will be calculated considering the mean number of visits/consultations/follow-ups and hospitalizations for patient and stratified in relation to severity of disease, frequency of bleeding and presence of inhibitors/comorbidities and haemophilia related complications or health problems.
Measured: Baseline until week 52
Estimate the impact of haemophilia and its treatment on patients reported outcomes
General health problems are defined by determinants like use of mobility aids and assistive devices, use of pain medication, presence of and how acute pain and chronic pain interfere with daily life, difficulty with daily activities, surgical history and concurrent medical problems and work/school life. Haemophilia-related health problems refer to disease severity, inhibitor status and history, bleeding frequency and history, treatment regimen and history and presence of target joint(s)
Measured: Baseline until week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start14 Nov 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophiliaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- EPOCH Study, Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454239
- Sponsor's protocol ID
- QTJC2024006
- Other IDs
- EPOCH Study, Ltd.
- Acronym
- EPOCH
- Status last verified
- Mar 2026
- First submitted
- 5 Jun 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPOCH-Economics and Patient Outcomes in China in Haemophilia
- ClinicalTrials.gov ID
- NCT07454239
- Acronym / sponsor ID
- EPOCH / QTJC2024006
- Conditions
- Hemophilia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Collaborators
- EPOCH Study, Ltd.
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Mar 2026 (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.
The overarching goal of the EPOCH project is to:
- Support a broad and robust needs assessment in the haemophilia space in China
- Measure the variability in the needs and care provision
- Generate outcome data (health economic outcomes and supporting clinical and PRO data) to enable measuring the impact of different treatment modalities and different levels of treatment access PRIMARY OBJECTIVES
- Determine the burden of haemophilia in China, and the determinants of its variability
- Determine the costs of haemophilia care in China, and the determinants of its variability SECONDARY OBJECTIVES
- Measure treatment patterns and their variability
- Measure levels of access to care
- Estimate the impact of haemophilia and its treatment of patients reported outcomes
- Understand consistency of care by centres/geography/demographics
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 12 minutes and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male patients, aged ≥12 years at the index date
Key inclusion criteria (3 listed)
- Male patients, aged ≥12 years at the index date
- Patients must be diagnosed with non-acquired severe haemophilia A or B prior to the previous 12 months
- Patients who are able to understand and assent / consent to the study
Key exclusion criteria (2 listed)
- Patients who cannot, for any reasons (language barriers, mental incapacity, etc.) understand and answer the questions of the study questionnaires
- Patients that cannot access internet connection or download the application
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Successfully registered research centers
Time frame: Baseline until week 52
Successfully registered research centers in Trial Phase
Number of enrolled patients
Time frame: Baseline until week 52
Number of enrolled patients in Trial Phase
Proportion of completed questionnaires
Time frame: Baseline until week 52
Proportion of completed questionnaires for the Trial Phase
Proportion of missing data
Time frame: Baseline until week 52
Proportion of missing data for the Trial Phase
Qualitative information on study barriers and facilitators
Time frame: Baseline until week 52
Qualitative information on study barriers and facilitators for the Trial Phase
Diagnostic and treatment burden for hemophilia patients
Time frame: Baseline until week 52
Diagnostic and treatment burden for hemophilia patients for the Implementation Phase
Costs of hemophilia diagnosis and treatment
Time frame: Baseline until week 52
Costs of hemophilia diagnosis and treatment for the Implementation Phase
3 secondary outcomes
Measure treatment patterns and their variability
Time frame: Baseline until week 52
Measure levels of access to care
Time frame: Baseline until week 52
Estimate the impact of haemophilia and its treatment on patients reported outcomes
Time frame: Baseline until week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hemophilia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Successfully registered research centers (time frame: Baseline until week 52). The study lists 7 primary outcomes in all. 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 6 Mar 2026.