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Clinical Trials/NCT07454239
NCT07454239Active, not recruitingNot Applicable

EPOCH-Economics and Patient Outcomes in China in Haemophilia

Institute of Hematology & Blood Diseases Hospital, China1 site in 1 country500 target enrollmentStarted: November 14, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
500
Locations
1
Primary Endpoint
Successfully registered research centers

Study Overview

Brief 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 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

Study Type
Observational
Observational Model
Case Only
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
12 Minutes to — (Child, Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Measure treatment patterns and their variability(Baseline until week 52)
  • Measure levels of access to care(Baseline until week 52)
  • Estimate the impact of haemophilia and its treatment on patients reported outcomes(Baseline until week 52)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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