FEIBA NF: A prospective, open-label, randomized, parallel study to evaluate efficacy and safety of prophylactic versus on-demand treatment in subjects with hemophilia A or B and a high titer inhibitor - FEIBA NF Prophylaxis Study

• Conditions: Hemophilia A or B and a high titer inhibitor; MedDRA version: 9.1Level: LLTClassification code 10056492Term: Haemophilia A with anti factor VIII; MedDRA version: 9.1Level: LLTClassification code 10056494Term: Haemophilia B with anti factor IX

• Registration Number: EUCTR2008-003855-65-BG
• Lead Sponsor: Baxter Innovations GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

- Signed and dated informed consent form by the subject or the subject’s legally authorized representative
- The subject is = 4 to = 65 years of age
- The subject has Karnofsky performance score of = 60
- Hemophilia A and B of any severity, with documented history of high-titer inhibitor (>5BU) for at least 12 months; or, if inhibitor titer is = 5 BU, and the subject is refractory with increased dosing of either FVIII or FIX, as demonstrated from the subject’s medical history
- Currently being treated on an on-demand basis for treatment of bleeding episodes
- Adequate venous access, with or without central venous device
- >/= 12 bleeding episodes in the past 12 months, based on medical history
- Competent in home treatment and infusion therapy
- Currently using bypassing agents (APCCs, or rFVIIa) for treatment of bleeding episodes
- HCV-, either by antibody testing or PCR; or HCV+ with stable hepatic disease
- HIV-, or HIV+ with stable disease and CD4 count > 200 cells/mm3 at screening
- Female subject of childbearing potential, presents with a negative serum pregnancy test, and agrees to employ adequate birth control measures for the duration of the study

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Currently receiving immune tolerance induction (ITI)
- Currently on regular prophylactic therapy to prevent bleeding episodes
- Clinically symptomatic liver disease (e.g. diagnosis of cirrhosis, [liver biopsy confirmed], portal vein hypertension, ascites, prothrombin time (PT) 5 seconds above upper limit of normal)
- Platelet count < 100,000/ml
- Planned elective surgery during participation in this study
- Subject is currently participating in another clinical study and has received an investigational product or device within 30 days prior to study entry
- Planned use of pegylated and non-pegylated alpha-interferon with or without ribavarin for HCV infected subjects or planned use of a protease inhibitor for HIV infected subjects. Subjects currently taking any of these medications for at least 30-days and who are clinically stable are eligible
- Clinically significant increase in D-dimer levels from historical baseline and/or associated with chronic liver disease or clinically evident thromboembolic event
- Known hypersensitivity to AICCs
- Currently treated with a systemic immunomodulating drug
- Prior history of thromboembolic event: acute myocardial infarction, deep vein thrombosis, or pulmonary embolism
- Diagnosis of advanced atherosclerosis, malignancy and/or other diseases that may increase the subject’s risk of thromboembolic complications
- Clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect subject safety or compliance

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified