EPOCH-Economics and Patient Outcomes in China in Haemophilia (EPOCH)

March 3, 2026 updated by: Institute of Hematology & Blood Diseases Hospital, China

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300020
        • Instiute of Hematology and Blood Diseases Hospital CAMS＆PUMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Male patients, aged ≥12 years at the index date

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Successfully registered research centers
Time Frame: Baseline until week 52
Successfully registered research centers in Trial Phase
Baseline until week 52
Number of enrolled patients
Time Frame: Baseline until week 52
Number of enrolled patients in Trial Phase
Baseline until week 52
Proportion of completed questionnaires
Time Frame: Baseline until week 52
Proportion of completed questionnaires for the Trial Phase
Baseline until week 52
Proportion of missing data
Time Frame: Baseline until week 52
Proportion of missing data for the Trial Phase
Baseline until week 52
Qualitative information on study barriers and facilitators
Time Frame: Baseline until week 52
Qualitative information on study barriers and facilitators for the Trial Phase
Baseline until week 52
Diagnostic and treatment burden for hemophilia patients
Time Frame: Baseline until week 52
Diagnostic and treatment burden for hemophilia patients for the Implementation Phase
Baseline until week 52
Costs of hemophilia diagnosis and treatment
Time Frame: Baseline until week 52
Costs of hemophilia diagnosis and treatment for the Implementation Phase
Baseline until week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Measure treatment patterns and their variability
Time Frame: Baseline until week 52

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.
Baseline until week 52
Measure levels of access to care
Time Frame: Baseline until week 52
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.
Baseline until week 52
Estimate the impact of haemophilia and its treatment on patients reported outcomes
Time Frame: Baseline until week 52
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)
Baseline until week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institute of Hematology & Blood Diseases Hospital, China

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
EPOCH Study, Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • QTJC2024006
  • EPOCH Study, Ltd. (Other Grant/Funding Number: EPOCH Study, Ltd.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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