Phase 3
Completed N=53
Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects
Source: ClinicalTrials.gov NCT00868530 ↗Enrolled (actual)
53
Serious AEs
17.0%
Results posted
Feb 2011
Primary outcomePrimary: Investigator Hemostatic Efficacy Assessment 8 Hours Post Infusion — 1.86 Units on a scale
Summary
This study will evaluate the safety and efficacy of on-demand treatment with Xyntha in Chinese hemophilia A subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Investigator Hemostatic Efficacy Assessment 8 Hours Post Infusion |
1.86 | — |
| PRIMARY Investigator Hemostatic Efficacy Assessment 24 Hours Post Infusion |
1.74 | — |
| PRIMARY Number of Participants With Factor VIII (FVIII) Inhibitor Development |
6; 1 | — |
| SECONDARY FVIII Recovery : Change From Baseline in FVIII Concentration |
-0.11 | 0.120 |
| SECONDARY Number of Participants With Less Than Expected Therapeutic Effect (LETE) |
— | — |
| SECONDARY Number of Participants With Thrombosis Allergic-Type Reactions |
1 | — |
| SECONDARY Number of Participants With Thrombosis |
— | — |
Eligibility Criteria
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 breastfeeding women
- Unwilling or unable to follow the terms of the protocol
- 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
Data sourced from ClinicalTrials.gov (NCT00868530). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.