A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
CSL Behring
Age
0–70
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
For previously treated subjects, either:
Completed a CSL-sponsored rIX-FP (CSL654) study, including study CSL654\_3001 \[NCT01496274\] or study CSL654\_3002 \[NCT01662531\].
Or:
Scheduled to have a major non-emergency surgery within approximately 8 weeks from the anticipated date of receiving the first rIX-FP injection.
Not previously completed a CSL-sponsored rIX-FP lead-in study.
Male, 12 to 70 years of age.
Documented severe hemophilia B (FIX activity of ≤ 2%), or confirmed at screening by the central laboratory.
Subjects who have received FIX products (plasma-derived and / or recombinant FIX) for \> 150 exposure days (EDs), confirmed by their treating physician.
No confirmed history of FIX inhibitor formation at screening by the central laboratory
For previously untreated subjects:
Male, up to 18 years of age.
Documented severe hemophilia B (FIX activity of ≤ 2%), or confirmed at screening by the central laboratory.
Never previously been treated with FIX clotting factor products (except previous exposure to blood components).
No confirmed history of FIX inhibitor formation
Surgery substudy inclusion criterion:
Must require non-emergency surgery
Male, at least 18 years of age.
Subjects currently enrolled in Study CSL654\_3003
Subjects who have received rIX-FP for ≥ 100 EDs (single-dose cohorts) or for ≥ 50 EDs (repeated-dose cohort)
You may not be if
Currently receiving a therapy not permitted during the study.
Any issue that, in the opinion of the investigator, would render the subject unsuitable for participation in the study.
For subjects who have previously completed a CSL-sponsored rIX-FP study:
Unwilling to participate in the study for a total of 100 exposure days.
For subjects requiring major non-emergency surgery who have not previously completed a CSL-sponsored rIX-FP lead-in study:
Known hypersensitivity (ie, allergic reaction or anaphylaxis) to any FIX product or hamster protein.
Known congenital or acquired coagulation disorder other than congenital FIX deficiency.
Currently receiving IV immunomodulating agents such as immunoglobulin or chronic systemic corticosteroid treatment.
Low platelet count, kidney or liver disease.
Human immunodeficiency virus positive with a CD4 count \< 200/mm3.
For previously untreated subjects:
Known congenital or acquired coagulation disorder other than congenital FIX deficiency (except for vitamin K deficiency of the newborn).
Known kidney or liver dysfunction or any condition which, in the investigator's opinion, place the patient at unjustifiable risk.
Intravenous use of rIX-FP within 14 days of subcutaneous administration of rIX-FP.
Life-threatening bleeding episode or major surgery during the 3 months prior to substudy entry
