Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects
NCT00868530
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- 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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects | |||
Official Title ICMJE | An Evaluation Of The Safety And Efficacy Of On-Demand Treatment With Xyntha (B Domain Deleted Recombinant Factor VIII, Albumin Free) In Chinese Subjects With Hemophilia A | |||
Brief Summary | This study will evaluate the safety and efficacy of on-demand treatment with Xyntha in Chinese hemophilia A subjects. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Hemophilia A | |||
Intervention ICMJE | Biological: Xyntha
Xyntha for on-demand treatment of bleeding episodes were according to investigator prescription during the 6 months observation period. The recovery assessed by determining the Factor VIII (FVIII) concentration (FVIII:C) levels in individual subjects at the initial and final visits. The dose of Xyntha for recovery assessments is: single 50 IU/kg (±5 IU/kg) IV bolus infusion. All Xyntha administrations occurred in the clinic (hospital). | |||
Study Arms ICMJE | Experimental: Xyntha
This trial was an open-label and included assessments of safety, clinical efficacy, and Factor VIII (FVIII) recovery in Chinese subjects with hemophilia A. Subjects received on-demand treatments with Xyntha over a 6-month (calendar day) period. Intervention: Biological: Xyntha | |||
Publications * | Yang R, Zhao Y, Wang X, Sun J, Wu R, Jin C, Jin J, Wu D, Rendo P, Sun F, Rupon J, Huard F, Korth-Bradley JM, Xu L, Luo B, Liu YC. Safety and Efficacy of Moroctocog Alfa (AF-CC) in Chinese Patients with Hemophilia A: Results of Two Open-Label Studies. J Blood Med. 2020 Nov 25;11:439-448. doi: 10.2147/JBM.S241605. eCollection 2020. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 53 | |||
Original Estimated Enrollment ICMJE | 50 | |||
Actual Study Completion Date ICMJE | December 2009 | |||
Actual Primary Completion Date | December 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 6 Years and older (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | China | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00868530 | |||
Other Study ID Numbers ICMJE | 3082B2-3316 B1831015 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | March 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |