Clinical Trials Logo
  1. Home
  2. Hemophilia A
  3. NCT04133883
  4. Details
NCT04133883 Clinical Trial

Impact on French Physician's Haemophilia Treatment Management Decision Based on Systematic Joint Examination

Hemophilia A Clinical Trial

— A-MOVE  

Official title:
A Study to Investigate if the Use of a Systematic Joint Examination (Ultrasound/Functional/Physical) Has an Impact on the Physician's Haemophilia Treatment Management Decision in Patients With Haemophilia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04133883
Other study ID # Sobi.HAEM8-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 13, 2020
Est. completion date July 13, 2022

Study information
Verified date January 2024
Source Swedish Orphan Biovitrum
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This low interventional study aims to describe if and how the haemophilia treatment management decisions are impacted by a systematic joint examination (ultrasound, functional, physical) in patients with haemophilia A in France.

Description:

The study will assess the behavior of the physicians with regards to haemophilia management decisions, and if systematic joint examination have an impact on their decisions. The main objective is to evaluate if the use of HEAD-US and Haemophilia Joint Health Score (HJHS) have an impact on these decisions. The study is classified as a low-interventional study due to mandated systematically assessment (HEAD-US, HJHS) on patients which may not be part of routine clinical practice.

Recruitment information / eligibility
Status Completed
Enrollment 88
Est. completion date July 13, 2022
Est. primary completion date July 13, 2022
Accepts healthy volunteers No
Gender All
Age group 6 Years to 40 Years
Eligibility Inclusion Criteria: - Age 6-40 years - Haemophilia A patients treated with plasma-derived factor VIII (pdFVIII) or recombinant (conventional or extended half-life) factor VIII (rFVIII) - At least one joint bleeding episode prior to inclusion - Signed informed consent Exclusion Criteria: - Enrolment in another concurrent clinical interventional study, or intake of an Investigational Medicinal Product, within three months prior to inclusion in the study - Presence of factor VIII antibodies (inhibitors) (=0.60 Bethesda Unit [BU]/mL) at the latest available inhibitor test - Joint surgery over the past year prior to inclusion in one of the following joints; left knee, right knee, left elbow, right elbow, left ankle and right ankle - More than one joint replacement

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Ultrasound, Haemophilia Joint Health Score
Systematic joint examinations of ankles, knees and elbows

Locations
Country Name City State
France Swedish Orphan Biovitrum Research site Angers
France Swedish Orphan Biovitrum Research site Bordeaux
France Swedish Orphan Biovitrum Research site Brest
France Swedish Orphan Biovitrum Research site Caen
France Swedish Orphan Biovitrum Research site Chambéry
France Swedish Orphan Biovitrum Research site Clermont-Ferrand
France Swedish Orphan Biovitrum Research site Dijon
France Swedish Orphan Biovitrum Research site Le Kremlin-Bicêtre
France Swedish Orphan Biovitrum Research site Lyon
France Swedish Orphan Biovitrum Research site Marseille
France Swedish Orphan Biovitrum Research site Montpellier
France Swedish Orphan Biovitrum Research site Nancy
France Swedish Orphan Biovitrum Research site Nantes
France Swedish Orphan Biovitrum Reserach site Paris
France Swedish Orphan Biovitrum Research site Poitiers
France Swedish Orphan Biovitrum Research site Reims
France Swedish Orphan Biovitrum Research site Rouen
France Swedish Orphan Biovitrum Research site Strasbourg
France Swedish Orphan Biovitrum Research site Toulouse
France Swedish Orphan Biovitrum Research Site Tours

Sponsors (2)
Lead Sponsor Collaborator
Swedish Orphan Biovitrum Cerner Enviza

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in haemophilia management based on systematic joint examinations of ankles, knees and elbows with HJHS and HEAD-US Yes/No 12 months
See also
  Status Clinical Trial Phase
Completed NCT03834727 - Characterizing the Impact and Treatment of Reproductive Tract Bleeding on Women and Post-menarchal Girls With Bleeding Disorders
Completed NCT03191799 - A Study to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors Phase 3
Completed NCT01599819 - BAX 855 Dose-Escalation Safety Study Phase 1
Terminated NCT04541628 - Safety & Efficacy of Encapsulated Allogeneic FVIII Cell Therapy in Haemophilia A Phase 1/Phase 2
Completed NCT02847637 - A Clinical Trial to Evaluate Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants Without Inhibitors Phase 3
Completed NCT04072237 - Study of Coagulation Faction VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia Phase 1
Completed NCT04085458 - Study to Gain More Information on How Safe and Effective Jivi Works in Patients With Severe Hemophilia A (Post-marketing Investigation) Phase 4
Completed NCT04565236 - A Post Approval Commitment Study to Gain More Information on How Safe and Effective KOVALTRY is in Chinese Children, Adolescents /Adults With Severe Hemophilia A Phase 4
Recruiting NCT05987449 - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A Phase 1/Phase 2
Active, not recruiting NCT04621916 - Preventing Inhibitor Recurrence Indefinitely Phase 4
Not yet recruiting NCT02888223 - Pharmacokinetic Study of SCT800 in Previously Treated Patients With Hemophilia A Phase 1
Completed NCT02528968 - National Study of a Pharmacokinetic-Focused Educational Package for Patients With Severe Haemophilia A N/A
Completed NCT02225483 - Phenotypic Heterogeneity in Hemophilia A: An Investigation of the Role of Platelet Function N/A
Completed NCT02199717 - An Institutional Pilot Study to Investigate Physical Activity Patterns in Boys With Hemophilia N/A
Completed NCT01217255 - Comparing the Burden of Illness of Hemophilia in the Developing and the Developed World
Completed NCT00969319 - Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America N/A
Terminated NCT00995046 - Individually Tailored Prophylaxis in Patients With Severe Hemophilia A N/A
Completed NCT00868530 - Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects Phase 3
Completed NCT00839202 - Activity and Content of Factor VIII (FVIII) in Human Plasma: The Assessment of a Novel Immunoassay N/A
Completed NCT00629837 - Pharmacokinetics and Safety of a Single Intravenous Infusion of BAY 79-4980 Phase 1