Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects (NCT00868530) | Clinical Trial Compass
CompletedPhase 3
Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects
China53 participantsStarted 2008-09
Plain-language summary
This study will evaluate the safety and efficacy of on-demand treatment with Xyntha in Chinese hemophilia A subjects.
Who can participate
Age range6 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects equal or more than 6 years of age with mild, moderate or severe hemophilia A (FVIII activity: more than 5%, 1-5%, or less than 1%, respectively)
* Subjects with previous exposure to FVIII replacement therapy
* If human immunodeficiency virus (HIV) positive, documented cluster of differentiation (CD4) count more than 200/µL within 6 months of study entry
Exclusion Criteria:
* Diagnosed with any bleeding disorder in addition to hemophilia A
* Current FVIII inhibitor or history of FVIII inhibitor (defined as positive result of the reporting laboratory)
* Subject has no history of exposure to FVIII products (previously untreated patient \[PUP\])
* Subject is currently utilizing primary FVIII prophylaxis
* Subjects anticipating elective surgery that may be planned to occur in the 6 months following study entry
* Treated with immunomodulatory therapy within 30 days prior to study entry or planned use for the duration of their study participation
* 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
* Subjects with a known hypersensitivity to hamster protein
* Significant hepatic or renal impairment (alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\] \>5 x upper limit of normal \[ULN\], bilirubin \>2 mg/dL or serum creatinine \>1.25 x ULN)
* Prothrombin Time \>1.5 x ULN
* Platelet count \<80,000 / µL
* Pregnant or …
What they're measuring
1
Investigator Hemostatic Efficacy Assessment 8 Hours Post Infusion
Timeframe: 8 hours post infusion
2
Investigator Hemostatic Efficacy Assessment 24 Hours Post Infusion
Timeframe: 24 hours post infusion
3
Number of Participants With Factor VIII (FVIII) Inhibitor Development
Timeframe: Day 1 and Month 6 or Early Termination Visit