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Status:

RECRUITING

Haemophilia and Bone Loss - PHILEOS Study

Lead Sponsor:

Centre Hospitalier Universitaire de Saint Etienne

Collaborating Sponsors:

Ministry of Health, France

Conditions:

Hemophilia

Eligibility:

MALE

20-60 years

Phase:

NA

Brief Summary

Haemophilia is a rare bleeding disorder, characterized by factor VIII (HA) or factor IX (HB) deficiency. The absence or the reduction of fVIII or fIX result in impaired thrombin generation and clot fo...

Detailed Description

Recruitment of healthy volunteers through registers (Clinical Investigation Centers) and advertisements. Recruitment of haemophilic patients during a routine visit at the haemophilia centre. Informa...

Eligibility Criteria

Inclusion

  • Healthy Volunteers :
  • Healthy men aged between 20 to 60 years old
  • Haemophilic Patients:
  • Haemophilia A and B patients, irrespective of the disease form (mild, moderate, severe with or without prophylaxis)
  • Haemophilic patients aged between 20 to 60 years old
  • Severe Haemophilia A patients with prophylaxis : last factor VIII injection more than 48 to 120 hours (depending on on the prophylactic treatment) prior blood sampling dedicated to the this research
  • Severe Haemophilia B patients : last factor IX injection more than 5 to 21 days (depending on the prophylactic treatment) prior blood sampling dedicated to the this research

Exclusion

  • Healthy Volunteers:
  • History of disease known to influence bone metabolism (hyperthyroidism, hyperparathyroidism, hypercorticism, hypogonadism, diseases that require long-term use of corticoids, …)
  • Past or present treatment with any osteoporotic medication other than Vit D or Ca++
  • Presence of two total hip prostheses
  • HIV documented infection
  • HCV documented infection (in progress or cured) at cirrhotic stage
  • Haemophilic Patients:
  • Haemophilic patients with current or history of inhibitor anti-fVIII or anti-fIX (\>5 Bethesda Units)
  • Treatment with HEMLIBRA (Emicizumab). Unless it is possible to use a result of thrombin generation prior to this treatment and achieved with a residual rate not greater than or equal to 5%.
  • History of disease known to influence bone metabolism and not related to haemophilia (hyperthyroidism, hyperparathyroidism, hypercorticism, hypogonadism, diseases that require long-term use of corticoids, …)
  • Past or present treatment with any anti-osteoporotic medication other than Vit D or Ca++
  • Presence of two total hip prostheses
  • HIV documented infection
  • HCV documented infection (in progress or cured) at cirrhotic stage

Key Trial Info

Start Date :

June 2 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2025

Estimated Enrollment :

480 Patients enrolled

Trial Details

Trial ID

NCT04384341

Start Date

June 2 2020

End Date

March 1 2025

Last Update

April 1 2025

Active Locations (23)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 6 (23 locations)

1

BELGIUM - Brussels

Brussels, Belgium

2

University Hospital Centre Zagreb

Zagreb, Croatia, 10000

3

Chu de Bordeaux

Bordeaux, France, 33076

4

Chu Brest Hopital Morvan

Brest, France, 29200