Hemophilia A Clinical Trial
— RELOQOfficial title:
Health Related Quality of Life of Youth and Young Adults With Haemophilia A Treated With Efmoroctocog Alfa in Russia
Verified date | December 2023 |
Source | The League of Clinical Research, Russia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Research question: Whether there are the changes in quality of life in patients with haemophilia A after switching from SHL FVIII prophylaxis to efmoroctocog alfa prophylaxis? A 12-month prospective open-label, single-arm multicentre study. Evaluation of parameters will be carried out on the backdrop of patient treatment in the settings of routine medical practice. No medical examinations/ procedures/ treatment(s) on the top of regular medical practice are planned, except fixed time of examinations.
Status | Completed |
Enrollment | 30 |
Est. completion date | February 20, 2023 |
Est. primary completion date | February 20, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 25 Years |
Eligibility | Inclusion Criteria: 1. Signed consent form. 2. Adults, adolescents and children (12-25 years old) with haemophilia A with ABR = 2 on at least one-year SHL FVIII prophylaxis. Exclusion Criteria: 1. Patients who have had hypersensitivity reactions to efmoroctocog alfa or other constituents of the product. 2. History of Factor VIII inhibitors. 3. Patients who have other haemostatic disorders. 4. Patients participating in interventional studies. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | League of Clinical Research (LeagueCRR) | Moscow |
Lead Sponsor | Collaborator |
---|---|
The League of Clinical Research, Russia |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Health-related quality of life | Haemophilia Adult Quality of Life Questionnaire (Haem-A-QoL) - for patients of 18-25 y.o.; total score, domain scores.
or Haemophilia-specific Quality of Life assessment for children and adolescents Short Form (Haemo-QoL SF) - for patients 12-17 y.o.; total score, domain scores. |
Month 12 | |
Secondary | Spontaneous bleedings | Number from previous visit | Month 1 - Month 3 - Month 6 - Month 12 | |
Secondary | Spontaneous bleedings - localisation | Localisation of spontaneous bleedings: joints, muscles, subcutaneous/ submucosal, abdominal/ gastrointestinal, retroperitoneal, genitourinary, CNS, pharyngeal, other. | Month 1 - Month 3 - Month 6 - Month 12 | |
Secondary | Post-traumatic bleedings | Number from previous visit | Month 1 - Month 3 - Month 6 - Month 12 | |
Secondary | Post-traumatic bleedings - localisation | Localisation of post-traumatic bleedings: joints, muscles, subcutaneous/ submucosal, abdominal/ gastrointestinal, retroperitoneal, genitourinary, CNS, pharyngeal, other. | Month 1 - Month 3 - Month 6 - Month 12 | |
Secondary | Administration of efmorococtog alfa for correction of bleedings | Dose of efmorococtog alfa: IU. | Month 1 - Month 3 - Month 6 - Month 12 | |
Secondary | Surgery/ Invasive Procedures: major | Number from previous visit. | Month 1 - Month 3 - Month 6 - Month 12 | |
Secondary | Surgery/ Invasive Procedures: minor | Number from previous visit. | Month 1 - Month 3 - Month 6 - Month 12 | |
Secondary | Administration of efmorococtog alfa for correction of bleedings for Surgery/ Invasive Procedures | Dose of efmorococtog alfa: IU. | Month 1 - Month 3 - Month 6 - Month 12 | |
Secondary | Hospitalisations | Number from previous visit. | Month 1 - Month 3 - Month 6 - Month 12 | |
Secondary | Hospitalisations: duration | Total duration of all hospitalisations: days. | Month 1 - Month 3 - Month 6 - Month 12 | |
Secondary | Hemophilia Joint Health Score | Hemophilia Joint Health Score 2.1 for knee, elbow, ankle (left, right): score. | Day 0 - Month 6 - Month 12 | |
Secondary | Target Joints | Target joints: knee, elbow, ankle, hip, shoulder, carpal, other (left, right): yes/ no. | Day 0 - Month 6 - Month 12 | |
Secondary | Ultrasound Scoring | Ultrasound scoring (HEAD-US): score. | Day 0 - Month 6 - Month 12 | |
Secondary | Factor VIII Activity | Factor VIII Activity (before injection; 30 min after injection), clotting assays (one stage): IU/dL. | Day 0 - Month 1 - Month 3 - Month 6 - Month 12 | |
Secondary | Factor VIII Inhibitor Activity | Factor VIII Inhibitor Activity: Nijmegen-Bethesda unit/mL. | Day 0 - Month 1 - Month 3 - Month 6 - Month 12 | |
Secondary | Administration of efmoroctocog alfa | Administration of efmoroctocog alfa, frequency: no. of injections per week. | Day 0 - Month 1 - Month 3 - Month 6 - Month 12 | |
Secondary | Administration of efmoroctocog alfa: factor consumption | Administration of efmoroctocog alfa, factor consumption: IU per week, IU/kg per week (calculation). | Day 0 - Month 1 - Month 3 - Month 6 - Month 12 | |
Secondary | Previous treatment/ prophylaxis of haemophilia | Generic drug name. | Day 0 - Month 1 - Month 3 - Month 6 - Month 12 |
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