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 range
6 Years
Sex
ALL
See this in plain English?
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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