EUCTR2014-004156-65-Outside-EU/EEAActive, not recruitingNot Applicable
An Evaluation of the Safety and Efficacy of On-Demand Treatment with BeneFIX (Nonacog Alfa, Recombinant Factor IX) in Chinese Subjects with Hemophilia B
Wyeth Pharmaceutical Co, Ltd.0 sites35 target enrollmentStarted: April 6, 2015Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 35
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Male
Inclusion Criteria
- •1.Subjects equal or more than 6 years of age with mild, moderate or severe hemophilia B (FIX activity: more than 5 percent (%), 1-5%, or less than 1%, respectively).
- •2.Subjects with previous exposure to FIX replacement therapy.
- •3. If HIV positive, documented cluster of differentiation (CD4) count more than 200 per microliter (mcL) within 6 months of study entry.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 35
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 26
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1.Diagnosed with any bleeding disorder in addition to hemophilia B.
- •2.Current FIX inhibitor or history of FIX inhibitor (defined as greater than (>) upper limit of normal [ULN] of the reporting laboratory).
- •3.Subject has no history of exposure to FIX products (previously untreated patient [PUP]).
- •4.Subject is currently utilizing primary FIX prophylaxis.
- •5.Subjects anticipating elective surgery that may be planned to occur in the 6 months following study entry.
- •6.Treated with immunomodulatory therapy within 30 days prior to study entry or planned use for the duration of their study participation.
- •7.Participated in another investigational drug or device study within 30 days prior to study entry or planned participation for the duration of their study participation.
- •8.Subjects with a known hypersensitivity to hamster protein.
- •9.Significant hepatic or renal impairment (alanine aminotransferase [ALT] and aspartate aminotransferase [AST] >5 * ULN, bilirubin >2 milligram per deciliter [mg/dL] or serum creatinine >1.25 * ULN).
- •10.Prothrombin Time >1.5 * ULN.
- •11.Platelet count less than (<) 80,000/mcL.
- •12.Pregnant or breastfeeding women.
- •13.Unwilling or unable to follow the terms of the protocol.
- •14.Any condition which may compromise the subject's ability to comply with and/or perform study-related activities or that poses a clinical contraindication to study participation, in the opinion of the Investigator or Sponsor.
Investigators
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