Case-control Pilot Study of the Immune Modulating Effect of FEIBA on Patients With Haemophilia A and Inhibitors

Severe Haemophilia A With Inhibitors Clinical Trial

Official title:

Case-control Pilot Study of the Immune Modulating Effect of FEIBA on Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02018393
• Other study ID #: PI-1405
• Status: Not yet recruiting
• Phase: N/A
• First received: December 17, 2013
• Last updated: December 20, 2013
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2013
• Source: Hospital Universitario La Paz
• Contact: Ihosvany Fernandez-Bello, Pharmacist
• Phone: +34669089737
• Email: ihosvanyf[@]yahoo.es
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines and Medical Devices
• Study type: Observational

Clinical Trial Summary

This study aims to evaluate the immunomodulatory effect of FEIBA® in patients with severe haemophilia A and inhibitors.

Description:

This is an observational, multicentric, case-control and one-single-visit study of patients with severe haemophilia A and inhibitors against FVIII in therapy with FEIBA®.

Two subject groups will be included: Group 1 (cases) will be composed of patients with severe haemophilia A and inhibitors in prophylaxis with FEIBA®; Group 2 (controls) will be composed of patients with severe haemophilia A and inhibitors on-demand treatment with FEIBA®.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The subject has signed and dated the Informed Consent form for participation in this study.

2. Age = 18 years old.

3. Patient with severe haemophilia A (FVIII <1%) and high-responding inhibitor (titre >5 UB) at some point in their life, currently on therapy with FEIBA® to control bleeding.

4. Group 1: Patients in prophylaxis with FEIBA®: The patient has been on prophylaxis regimen with FEIBA® for at least 6 months prior to the study visit. Group 2: Patients on-demand regimen with FEIBA®: The patient has been under on-demand treatment with FEIBA® for at 6 months prior to the study visit.

Exclusion Criteria:

1. The presence of any inflammatory condition at the time of the study visit or the previous 30 days that, according to the medical criterion, would affect the study objectives.

2. The patient is under immune tolerance treatment or has been at any time during the 30 days prior to the study visit.

3. The administration of any anti-inflammatory or immunosuppressive drug 15 days before the study visit.

4. Levels of CD4 <200/l regardless of the HIV status.

5. Altered hepatic or renal function defined by the presence of abnormal levels of alanine aminotransferase (ALAT) or serum creatinine, respectively.

6. Administration of any haemostatic treatment to control bleeding within the 5 days prior to the study visit.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hemophilia A
• Severe Haemophilia A With Inhibitors

Locations

Country	Name	City	State
Spain	University Hospital La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of plasma levels of anti-FVIII antibodies (neutralising and non-neutralising)		At inclusion	No
Secondary	Measurement of the serum levels of inflammatory cytokines		At inclusion	No