Hemophilia B

Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein in Subjects With Hemophilia B

NCT01233440 | PHASE 1 | INTERVENTIONAL

The primary objective of the study is to assess the safety of IV administration of rIX-FP. Safety will be evaluated by adverse events and laboratory changes over time. The secondary objective of the study is to evaluate the pharmacokinetics parameters, following a single intravenous dose of rIX-FP.

20 Sites

25 Participants

Recruiting

12 Years to 65 Years

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SUBMIT

Study site

Vienna,Austria

Study site

Le Kremlin-Bicetre,France

Study Site

Lyon,France

Study site

Nantes,France

Study site

Paris,France

Study Site

Berlin,Germany

Study Site

Hamburg,Germany

Study Site

Hannover,Germany

Study site

Munster,Germany

Study Site

Tel Hashomer,Israel

Study Site

Catania,Italy

Study Site

Firenze,Italy

Study Site

Genova,Italy

Study site

Milan,Italy

Study Site

Napoli,Italy

Study Site

Parma,Italy

Study Site

Vicenza,Italy

Study Site

A Coruna,Spain

Study Site

Barcelona,Spain

Study Site

Madrid,Spain

Study Eligibility Criteria

Inclusion Criteria

* Male, 12 - 65 years, with body weight ≥ 30 kg and ≤ 120 kg
* Documented severe Hemophilia B (FIX activity of ≤ 2%) or tested by the central laboratory at screening
* Subjects who have received FIX products for \> 150 exposure days (EDs) (estimated)
* No confirmed prior history of FIX inhibitor (history of positive FIX inhibitor defined as two consecutive positive tests - a confirmatory test on a second, separately drawn sample shortly after the previous positive test) and confirmed no detectable FIX inhibitors (negative FIX inhibitor defined as \< 0.6 Bethesda Units \[BU\] by the central laboratory at screening
* Subjects can be treated on-demand or under prophylactic therapy
* Signed Informed Consent/Assent

Exclusion Criteria

* Known hypersensitivity (allergic reaction or anaphylaxis) to any FIX product or hamster protein
* Any known congenital or acquired coagulation disorder other than congenital FIX deficiency
* Platelet count \< 100,000/µL
* Immunocompromised (CD4 count \< 200/mm3), (HIV positive subjects may participate in the study and protease inhibitors and antiviral therapy are permitted, at the discretion of the Investigator)
* Currently receiving IV immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment
* Serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT) concentration \> 5 times (x) the upper limit of normal (ULN)
* Serum creatinine \> 2 x ULN
* Evidence of thrombosis, including deep vein thrombosis, stroke, pulmonary embolism, myocardial infarction and arterial embolus within 3 months prior to enrollment
* Use of an Investigational Medicinal Product (IMP) within 30 days prior to the first rIX-FP administration
* Experienced life-threatening bleeding episode or had major surgery or an orthopedic surgical procedure during the 3 months prior to study entry
* Subject currently on a dose and/or regimen of FIX that would preclude participation in the study due to possible increased risk of bleeding because of the requirement to withhold treatment during the PK sampling period
* Suspected inability (e.g., language problem or mental condition) or unwillingness to comply with study procedures or history of noncompliance

Additional Studies

Additional studies can be found at ClinicalTrials.gov