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NCT04728217 Clinical Trial

Health Related Quality of Life of Youth and Young Adults With Haemophilia A

Hemophilia A Clinical Trial

— RELOQ  

Official title:
Health Related Quality of Life of Youth and Young Adults With Haemophilia A Treated With Efmoroctocog Alfa in Russia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04728217
Other study ID # RELOQ
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 15, 2021
Est. completion date February 20, 2023

Study information
Verified date December 2023
Source The League of Clinical Research, Russia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

Quality of life is among the key factors when medical decision about management of haemophilia is taken. There are no scientific data on the HRQoL in patients after switching from Standard Half Life (SHL) FVIII prophylaxis to efmoroctocog alfa (Extended Half Life, EHL) prophylaxis in Russia. It will be 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. Providing the centers/ patients with the study drug (efmoroctocog alfa) may be considered as interventional component, whereas all administrations should be in accordance with Instruction on Medical Use approved by Russian Ministry of Health. 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? No hypothesis is formulated for this exploratory study. The obtained data will be used to assess real world data on quality of life and clinical outcomes in patients with haemophilia A after switching from SHL FVIII prophylaxis to efmoroctocog alfa prophylaxis in routine medical practice in Russia

Recruitment information / eligibility
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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Efmoroctocog Alfa Injection [Eloctate]
Efmoroctocog alfa should be administered according to Summary of Product Characteristics (SmPC)/ Instruction on Medical Use approved by Russian Ministry of Health ??-006034 (13.01.2020).

Locations
Country Name City State
Russian Federation League of Clinical Research (LeagueCRR) Moscow

Sponsors (1)
Lead Sponsor Collaborator
The League of Clinical Research, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome
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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