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Enrolling by invitation NCT07163260

Defeat Rare Disease in Asia and Pacific (APAC) DRDA - Haemophilia

Observational Haemophilia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No treatment given.
Who it may be relevant to
Registry conditions: Haemophilia. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India, Malaysia, South Korea, Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This study will help to better understand the course of disease in people with haemophilia (A or B \[with or without inhibitors\]) and the haemophilia care scenario in the selected countries and the experience so far in dealing with the condition. This is a survey-based study; hence no medications or other treatments will be provided to participants as a part of this study.

Interventions

  • Other No treatment given
    No treatment given

Primary outcome measures

  • Estimated prevalence of haemophilia [Time frame: From start of data collection to end of data collection (approximately 5 months)]
  • Estimated incidence of haemophilia [Time frame: From start of data collection to end of data collection (approximately 5 months)]
  • Estimated proportion of patients with haemophilia (PWH) who develop inhibitors (%) [Time frame: From start of data collection to end of data collection (approximately 5 months)]

Eligibility criteria

Inclusion criteria

For Experienced/Senior Treating Physicians

  • Experienced/senior haematologist treating haemophilia (adult or paediatric) or physician treating patients with haemophilia. (PWH), with greater than 5 years of experience.
  • Able to communicate in English or country specific language.
  • Agree/sign informed consent before data collection. For Patients Organisations
  • Patient organisation supporting haemophilia.
  • Expert having greater than 3 years of work experience with the patient organisation.
  • Expert level understanding of haemophilia landscape and care pathway in the relevant country.
  • Able to communicate in English or country specific language.
  • Agree/sign informed consent before data collection. For Patients/Caregivers
  • Patients of all age groups, diagnosed with haemophilia A or haemophilia B (with or without inhibitors) for greater than 2 years.
  • For patients less than 18 years of age (\*less than 19 years for South Korea), their caregivers aged greater than or equal to 18 years (\*greater than or equal to19 years for South Korea) should sign the informed consent.

\*For South Korea, the adult age is 19 years.

  • Able to communicate in English or country specific language.
  • Agree/sign informed consent before data collection.

Exclusion criteria

  • There is no explicit exclusion criterion in this study, thus any participants group who answers "no" to any of the inclusion criteria will be excluded from the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

India · 1 center
  • Novo Nordisk Investigational Site — Bangalore
Malaysia · 1 center
  • Novo Nordisk Investigational Site — Kuala Lumpur
South Korea · 1 center
  • Novo Nordisk Investigational Site — Seoul
Thailand · 1 center
  • Novo Nordisk Investigational Site — Bangkok

Identifiers

NCT: NCT07163260 · DAS-8107 · U1111-1303-7372

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗