Study of Recombinant Factor IX Product, IB1001, in Previously Treated Subjects With Hemophilia B

Withdrawn before enrolling · Phase 3

Conditions studied: Hemophilia B

In brief

To evaluate the safety (acute adverse effects associated with infusions, and inhibitor development), pharmacokinetics (PK), and efficacy with respect to breakthrough bleeding and control of hemorrhaging during prophylaxis of IB1001 in subjects with hemophilia B.

Key facts

Study ID

NCT02048111

Run by

Cangene Corporation

People needed

0

Starts

2014-03-01

Expected to finish

2015-11-01

Last updated by the study team

2016-08-23

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age of at least 12 years
• Body Mass Index of ≤ 29, with a minimum body weight of 40 kg
• Written Institutional Review Board (IRB)/ Ethics Committee (EC)-approved informed consent form (ICF)
• Willingness to make the required study visits, and follow instructions while enrolled in the study (up to 12 months)
• Severe (factor IX activity ≤2 U/dL) hemophilia B patients with a minimum of 3 bleeding episodes over the preceding 6 months or 6 bleeding episodes over the preceding 12 months or in the event the subject is on prophylaxis, a minimum of 3 bleeding episodes over the preceding 6 months or 6 bleeding episodes over the preceding 12 months prior to being placed on prophylaxis
• Subjects must be on prophylaxis or switch to a prophylaxis regimen for the duration of the PK and Treatment/Continuation Phase of the study
• Previously treated patients with a minimum of 150 exposure days to a factor IX preparation
• Willingness to adhere to the 5-day washout of any factor IX replacement therapy prior to PK evaluations
• Immunocompetent (CD4 count >400/mm3) and not receiving immune modulating or chemotherapeutic agents
• Platelet count at least 150,000/mm3
• Liver function: alanine transaminase (ALT) and aspartate transaminase (AST) ≤2 times the upper limit of the normal range
• Total bilirubin ≤1.5 times the upper limit of the normal range
• Renal function: serum creatinine ≤1.25 times the upper limit of the normal range
• Hemoglobin ≥7 g/dL at the time of the blood draw

You may not qualify if…

• History of factor IX inhibitor ≥0.6 BU (Bethesda units)
• Existence of another coagulation disorder
• Evidence of thrombotic disease, fibrinolysis or disseminated intravascular coagulation (DIC)
• Use of an investigational drug within 30 days prior to study entry
• Previous use of IB1001
• Use of medications that could impact hemostasis, such as aspirin
• Hypersensitivity to the active substance or to any of the excipients in the investigational products
• Known allergic reaction to hamster proteins
• History of poor compliance, a serious medical or social condition, or any other circumstance that, in the opinion of the investigator, would interfere with participation or compliance with the study protocol
• History of adverse reaction to either plasma-derived factor IX or recombinant factor IX that interfered with the subject's ability to treat bleeding episodes with a factor IX product

Where it is running

• Study site — Chicago, Illinois, United States
• Study site — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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