Study Evaluating On-Demand Treatment With BeneFIX in Chinese Subjects
- Conditions
- Hemophilia BMedDRA version: 17.1Level: LLTClassification code 10060614Term: Hemophilia B (Factor IX)System Organ Class: 100000004850Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2014-004156-65-Outside-EU/EEA
- Lead Sponsor
- Wyeth Pharmaceutical Co, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- Male
- Target Recruitment
- 35
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To describe the safety and clinical efficacy of BeneFIX in previously treated Chinese subjects with hemophilia B.;Secondary Objective: To describe FIX recovery after exposure to BeneFIX in previously treated Chinese subjects with hemophilia B. Incidence of less than expected therapeutic effect (LETE). Average frequency of injection treatment for 1 hemorrhage incidence. Average dose of BeneFIX per hemorrhagic event.;Primary end point(s): 1. Investigator Hemostatic Efficacy Assessment of Subjects After 8 Hours Post Infusion<br>2. Investigator Hemostatic Efficacy Assessment of Subjects After 24 Hours Post Infusion<br>3. Percentage of Subjects With FIX Inhibitor Development;Timepoint(s) of evaluation of this end point: 1. 8 hours post infusion<br>2. 24 Hours Post Infusion<br>3. Baseline up to 6 months<br>
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: 1. Baseline up to 6 months<br>2. Baseline (Visit 2) up to 6 months (Visit 4)<br>3. Baseline up to 6 months<br>4. Baseline up to 6 months<br>5. Baseline up to 6 months<br>6. Baseline up to 6 months<br>;Secondary end point(s): 1. Number of Infusions Required to Treat Each Bleed<br>2. FIX Incremental Recovery<br>3. Percentage of Subjects With Less Than Expected Therapeutic Effect (LETE)<br>4. Percentage of Subjects With Allergic-Type Allergic Reactions<br>5. Percentage of Subjects With Thrombosis<br>6. Percentage of Subjects With Red Blood Cell (RBC) Agglutination