NCT05044845Completed
Needs Assessment of Knowledge, Beliefs, and Attitudes of Patients With Hemophilia B About Gene Therapy
Needs Assessment of Knowledge, Beliefs, and Attitudes of Patients With Hemophilia B About Gene Therapy Globally
Source: ClinicalTrials.gov · Last updated 14 Nov 2025
Brief summary (registry, in English)
Gene therapy is a paradigm-shifting treatment for hemophilia B patients, particularly in resource-limited countries where factor availability remains low. Transparent and culturally sensitive communication around gene therapy is vital to the success of a high-quality consenting process. Current literature on knowledge, beliefs and attitudes about gene therapy in resource-limited countries is inadequate. In addition, few educational resources to explain basic gene therapy concepts exist in languages other than English. This study aims to address these gaps in knowledge and aid for the development of educational resources to assist the informed consent processes for gene therapy in resource-limited countries. Primary Objective: To assess baseline knowledge, beliefs, and attitudes about gene therapy held by hemophilia B patients globally Secondary Objectives: 1. To explore healthcare workers' (i.e., physicians, nurses, social workers, educators/academic coordinators) perspectives regarding the education needs of hemophilia B patients globally 2. To explore healthcare workers beliefs and attitudes about gene therapy 3. To identify preferences of patients with hemophilia B and their healthcare workers on how/by what method or pathway educational content should be provided.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 150 (actual)
- First submitted
- 9 Sept 2021
- Start date
- 18 Jan 2022
- Primary completion date
- 14 Oct 2025
- Lead sponsor
- St. Jude Children's Research Hospital
- Diseases
- Haemophilia
- NCT number
- NCT05044845
What you commit to
- Study type: Observational
- Participants enrolled: 150
- From 18 Jan 2022 to the primary completion date, 14 Oct 2025
- 6 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosis of other non-Hemophilia B bleeding disorders
Other
- Diagnosis of Hemophilia A
- Health care workers who do not participate in the care of hemophilia B patients
- Healthcare worker who is conducting the interviews
Who the study is looking for
- Patients ≥12 years of age
- Diagnosis of moderate (FIX ≥1% and ≤2%) or severe (\<1%) hemophilia B
- Parents or caregivers to patients with hemophilia 12-17 years of age
- \- Doctors, nurses, social workers, pharmacists and educators who participate in the care of hemophilia B patients
Age in the registry: 12 years to - · Sex: All
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Hospital of Sri Lanka Coordinator of this site? Confirm its status | Colombo | Sri Lanka | Unknown status |
| Civil Service Hospital Coordinator of this site? Confirm its status | Kathmandu | Nepal | Unknown status |
| Hospital Dos De Mayo Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
| Ramathibodi Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| St. Jude Children's Research Hospital Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| National Institute of Hematology and Blood Transfusion Coordinator of this site? Confirm its status | Hanoi | Vietnam | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.