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An Observational Study to Evaluate Physical Activity, Bleeding Incidence and Health Related Quality of Life, in Participants With Haemophilia A Without Inhibitors Receiving Standard of Care Treatment | Clinical Trials | Clareo Health

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An Observational Study to Evaluate Physical Activity, Bleeding Incidence and Health Related Quality of Life, in Participants With Haemophilia A Without Inhibitors Receiving Standard of Care Treatment

A Multicenter, Non-Interventional Study to Evaluate Physical Activity, Bleeding Incidence and Health Related Quality of Life, in Patients With Haemophilia A Without Inhibitors Receiving Standard of Care Treatment

NCT04165135•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This multicenter, non-interventional, prospective study will collect information about activity status, bleeds, health-related quality of life (HRQoL), health status, and safety in participants with moderate or severe haemophilia A without factor VIII (FVIII) inhibitors, who are being treated in accordance with normal clinical practice.

Eligibility

Age

12 - 50 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Must own a device compatible with the electronic Patient-Reported Outcome (ePRO) application and with the fitness tracker that will be provided to the patient
•Must have on his/her own device a data traffic availability of at least 2 gigabytes (GB) in total per month intended only for use of study applications and data transfer. If the data traffic plan is exhausted, the participant must be able to connect to a wi-fi network at least once every day in order to transfer the data collected for the study purpose
•Must accept to run on his/her own device the ePRO application and the fitness tracker application
•Must be available to turn on daily the bluetooth connection of his/her own device in order to allow the synchronization with the fitness tracker
•Ability and willingness to comply with all aspects of the protocol, including completion of questions on the ePRO application (for underage population, ePRO questions can be answered by legally authorized representative if deemed necessary)
•Ability and willingness to wear the activity tracking device as indicated
•Diagnosis of severe (FVIII \<1%) or moderate (FVIII ≥1% and ≤2%) congenital haemophilia A
•No prior history of a positive inhibitor against FVIII. If participant has a previous history of inhibitor development, the participant must have successfully eradicated inhibitors since 3 years.
•At least 150 exposure days of FVIII prior to enrolment

Exclusion Criteria

•Bleeding disorder other than congenital haemophilia A
•Ongoing (or planned during the study) immune tolerance induction or FVIII prophylaxis if the participant has currently low titre of inhibitors or had inhibitors in the past 3 years
•Previous or concomitant autoimmune or connective tissue disease
•History of or suspected allergy or intolerance to any of the component of the fitness device (e.g., aluminium anodised)
•History of clinically significant hypersensitivity associated with monoclonal antibody
•Obesity (Body Mass Index \[BMI\] ≥30 kilograms/metre squared of body surface area \[kg/m\^2})
•Clinically important cardiovascular, metabolic, endocrine disorders or any other concomitant diseases or conditions that could limit the mobility of participant or could represent any risk according to the Investigator's judgment, or that could interfere with the study evaluation parameters
•Participation in any other interventional clinical trial, including Roche sponsored studies or in any other support program that may include drug administration other than standard clinical practice (e.g., compassionate use, use not in agreement with the authorized indications, patient support programs, etc.)

Locations (17)

AOU Cons. Policlinico Bari; Centro Emofilia e Trombosi - UO Medicina Trasfusionale

Bari, Apulia, Italy

Az. Osp. Pugliese Ciaccio; S. C. Emofilia, Emostasi e Trombosi

Catanzaro, Calabria, Italy

AOU Federico II; Medicina Clinica Chirurgia Centro Emocoaugulopatie e Emofilia

Naples, Campania, Italy

PO Cesena - Osp M. Bufalini; Patologia Clinica - S.S.A. Serv. Medicina Trasf.- Centro Emofilia

Cesena, Emilia-Romagna, Italy

Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol

Rome, Lazio, Italy

Ospedale Pediatrico Bambino Gesù; Oncoematologia Centro Emostasi e Trombosi

Rome, Lazio, Italy

Policlinico Univ. A. Gemelli; Polo di Scienze Oncologiche ed Ematologiche

Rome, Lazio, Italy

IRCCS Ca' Granda Ospedale Maggiore Policlinico; Centro Emofilia e Trombosi "Angelo Bianchi e Bonomi"

Milan, Lombardy, Italy

Fondazione IRCCS Policlinico San Matteo; S.C. Medicina Generale 2 - Centro Emofilia

Pavia, Lombardy, Italy

A.O.Santi Antonio e Biagio e Cesare Arrigo; S.S. Emostasi e Trombosi - Dip. Onco-Ema e Med Spec.

Alessandria, Piedmont, Italy

Key Dates

Start Date

February 24, 2020

Primary Completion Date

April 28, 2022

Completion Date

April 28, 2022

Last Updated

July 12, 2024

Enrollment

103

ACTUAL participants

Conditions

Severe Hereditary Factor VIII Deficiency Disease Without InhibitorModerate Hereditary Factor VIII Deficiency Disease Without InhibitorHaemophilia A

Interventions

Standard of Care for Haemophilia A

DRUG

Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors

NCT06285071

Haemophilia AHaemophilia B

View study

ENROLLING_BY_INVITATION

Post-marketing Surveillance (Special Use-results Surveillance) on Treatment With Alhemo

NCT06831734

Haemophilia A, Haemophilia B

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

An Observational Study to Evaluate Physical Activity, Bleeding Incidence and Health Related Quality of Life, in Participants With Haemophilia A Without Inhibitors Receiving Standard of Care Treatment

Inclusion Criteria

Exclusion Criteria

Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors

Post-marketing Surveillance (Special Use-results Surveillance) on Treatment With Alhemo

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