Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00868530
First received: March 19, 2009
Last updated: April 1, 2011
Last verified: April 2011

March 19, 2009
April 1, 2011
September 2008
December 2009   (final data collection date for primary outcome measure)
  • Investigator Hemostatic Efficacy Assessment 8 Hours Post Infusion [ Time Frame: 8 hours post infusion ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.
the response of bleeding episodes to Xyntha treatment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00868530 on ClinicalTrials.gov Archive Site
  • FVIII Recovery : Change From Baseline in FVIII Concentration [ Time Frame: Day 1 and Month 6 or Early Termination Visit ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Number of Participants With Thrombosis [ Time Frame: Baseline up to 6 months ] [ Designated as safety issue: Yes ]
the number of infusions required to resolve bleeding episodes; the incidence of less than expected therapeutic effect (LETE) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects
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

This study will evaluate the safety and efficacy of on-demand treatment with Xyntha in Chinese hemophilia A subjects.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hemophilia A
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).
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
6 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00868530
3082B2-3316, B1831015
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP