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Trial record 1 of 1 for:    NCT00868530
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Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects

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ClinicalTrials.gov Identifier: NCT00868530
Recruitment Status : Completed
First Posted : March 25, 2009
Results First Posted : February 8, 2011
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 19, 2009
First Posted Date  ICMJE March 25, 2009
Results First Submitted Date  ICMJE December 3, 2010
Results First Posted Date  ICMJE February 8, 2011
Last Update Posted Date April 5, 2017
Study Start Date  ICMJE September 2008
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2011)
  • Investigator Hemostatic Efficacy Assessment 8 Hours Post Infusion [ Time Frame: 8 hours post infusion ]
    The Investigator Hemostatic Efficacy Assessment was based on a 4-point rating scale (Excellent = 1: definite pain relief or improvement in signs of bleeding, with no additional infusion, Good = 2: definite pain relief or improvement in signs of bleeding, Moderate = 3: probable or slight improvement, No Response = 4: no improvement at all between infusions).
  • Investigator Hemostatic Efficacy Assessment 24 Hours Post Infusion [ Time Frame: 24 hours post infusion ]
    The Investigator Hemostatic Efficacy Assessment was based on a 4-point rating scale (Excellent = 1: definite pain relief or improvement in signs of bleeding, with no additional infusion, Good = 2: definite pain relief or improvement in signs of bleeding, Moderate = 3: probable or slight improvement, No Response = 4: no improvement at all between infusions).
  • Number of Participants With Factor VIII (FVIII) Inhibitor Development [ Time Frame: Day 1 and Month 6 or Early Termination Visit ]
    Incidence of FVIII inhibitor was defined as any result determined as positive at local laboratory, and confirmed at central laboratory. Incidence was stratified by participant exposure history: Minimally Treated Patients (MTPs): those who had received at least 1 prior FVIII infusion, and <= 100 documented Exposure Days (EDs), while Previously Treated Patients (PTPs): those who had received >100 documented prior EDs. When number of prior EDs for an individual was not known to be at least 100, participants were included in the MTP population.
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2009)
the response of bleeding episodes to Xyntha treatment [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2011)
  • FVIII Recovery : Change From Baseline in FVIII Concentration [ Time Frame: Day 1 and Month 6 or Early Termination Visit ]
    FVIII recovery was assessed by evaluating the change in FVIII concentration at 6 months compared to baseline.
  • Number of Participants With Less Than Expected Therapeutic Effect (LETE) [ Time Frame: 24 hours after each of 2 successive infusion, up to 6 months ]
    The incidence of LETE, defined for on-demand treatment as no response after each of 2 successive infusions within 24 hours for the same bleeding event in the absence of confounding factors.
  • Number of Participants With Thrombosis Allergic-Type Reactions [ Time Frame: Baseline up to 6 months ]
  • Number of Participants With Thrombosis [ Time Frame: Baseline up to 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2009)
the number of infusions required to resolve bleeding episodes; the incidence of less than expected therapeutic effect (LETE) [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures
 (submitted: March 7, 2017)
  • Frequency of Xyntha Infusions Required Per Hemorrhage [ Time Frame: Day 1 to Month 6 or Early Termination Visit ]
    The mean frequency of Xyntha infusions per hemorrhage was calculated as total number of injections throughout the study divided by total number of hemorrhagic events.
  • Average Dose of Xyntha Infusions Required Per Hemorrhage [ Time Frame: Day 1 to Month 6 or Early Termination Visit ]
    The average dose of Xyntha per hemorrhagic event was calculated as total dose of Xyntha throughout the study (in IU) divided by total number of hemorrhage incidence.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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 * Not Provided

*   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
 (submitted: November 5, 2010)
53
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2009)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Study Director: Pfizer CT.gov Call Center Pfizer
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