NCT04675541

Brief Summary

Record real life data of patients with Hemophilia A and treated with Afstyla® to assess the effectiveness and the safety of the treatment used as prophylaxis, prevention of bleeding (e.g. surgery) or on-demand treatment during 3 years after patient inclusion

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2018

Longer than P75 for all trials

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2018

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

6.3 years

First QC Date

December 1, 2020

Last Update Submit

January 7, 2025

Conditions

Haemophilia A

Keywords

FVIIICoagulation FVIII

Outcome Measures

Primary Outcomes (4)

  • The annualized bleeding rate (spontaneous, traumatic) during long term prophylactic and on demand regimen.

    Up to 36 months

  • The number of spontaneous bleeding episodes per patient

    Up to 36 months

  • The number of infusions of Afstyla® required for the prevention and resolution of non-surgical bleeding episodes

    Up to 36 months

  • The total dose of Afstyla® required for the prevention and resolution of non-surgical bleeding episodes

    Up to 36 months

Secondary Outcomes (3)

  • The number of infusions of Afstyla® required during the surgical procedures

    Up to 36 months

  • The total dose of Afstyla® required during the surgical procedures

    Up to 36 months

  • The incidence of adverse events (AE), severe AE, and AE related to Afstyla®

    Up to 36 months

Interventions

Afstyla®BIOLOGICAL

Solution for injection

Also known as: CSL627

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Haemophilia A French patients treated with Afstyla®

You may qualify if:

  • Have given their agreement to take part in the observational registry after being informed in writing of the purposes of the study and after their data have been recorded (parent's agreement for minor patients);
  • Be suffering from haemophilia A and being treated or having been treated with Afstyla® long term prophylactically, on demand or preventatively for a surgical procedure;

You may not qualify if:

  • Refusal of the patient or the patient's legal representative to take part in the study;
  • Existence of a contraindication to the use of Afstyla® treatment (known hypersensitivity to FVIII or hamster proteins);
  • Simultaneous participation in an interventional clinical study.
  • Presence of an inhibitor and/or ongoing immune tolerance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

CHU Brest

Brest, France

Location

CHU Caen

Caen, France

Location

CHU Chambéry

Chambéry, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

Hôpital Simone Veil

Eaubonne, France

Location

Hôpital Mignot

Le Chesnay, France

Location

CRC-MHC Hôpital Kremlin Bicêtre

Le Kremlin-Bicêtre, France

Location

CHRU Lille

Lille, France

Location

CHU Limoges

Limoges, France

Location

CHU Montpellier

Montpellier, France

Location

CHU Nantes

Nantes, France

Location

Hôpital Necker

Paris, France

Location

CHU Rennes

Rennes, France

Location

CHU Rouen

Rouen, France

Location

CHU Saint-Etienne

Saint-Etienne, France

Location

Hôpital Hautepierre

Strasbourg, France

Location

CHRU de Tours

Tours, 37044, France

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

Factor VIII

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Blood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsProtein PrecursorsBiological Factors

Study Officials

  • Study Director

    CSL Behring SA

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2020

First Posted

December 19, 2020

Study Start

September 24, 2018

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

January 8, 2025

Record last verified: 2025-01

Locations

FR(17)