Clinical Trial: Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Congenital Hemophilia A
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Patients With Congenital Hemophilia A With Factor VIII Inhibitors
Brief Summary: This study is to test whether the study drug (OBI-1) is safe and effective for the treatment of serious bleeding episodes in people with congenital hemophilia A.
Detailed Summary:
Sponsor: Baxalta US Inc.
Current Primary Outcome: Proportion of Serious Bleeding Episodes Responsive to OBI-1 [ Time Frame: 24 hours after initiation of treatment ]
Original Primary Outcome: Proportion of Serious Bleeding Episodes Responsive to OBI-1 [ Time Frame: 24 hours after initiation of treatment ]
Current Secondary Outcome:
- Overall Proportion of Serious Bleeding Episodes Successfully Controlled With OBI-1 Therapy, as Assessed by the Investigator. [ Time Frame: Through 90 days ± 7days following final OBI-1 dose ]
- Proportion of Bleeding Episodes Responsive to OBI-1 Therapy at Designated Assessment Time Points After the Initiation of Therapy, as Assessed by the Investigator [ Time Frame: Through 90 days ± 7days following final OBI-1 dose ]
- Frequency of Infusions of OBI-1 Required to Successfully Control Qualifying Bleeding Episodes. [ Time Frame: Through 90 days ± 7days following final OBI-1 dose ]
- Total Dose of OBI-1 Required to Successfully Control Qualifying Bleeding Episodes. [ Time Frame: Through 90 days ± 7days following final OBI-1 dose ]
- Total Number of Infusions of OBI-1 Required to Successfully Control Qualifying Bleeding Episodes. [ Time Frame: Through 90 days ± 7days following final OBI-1 dose ]
- Correlation Between Response to OBI-1 Therapy at Specified Time Points and Eventual Control of Serious Bleeding Episodes. [ Time Frame: Through 90 days ± 7days following final OBI-1 dose ]
- Correlation Between the Pre-infusion Anti-OBI-1 Antibody Titers, the Total Dose of OBI-1, the Outcome at 24 Hours and the Eventual Control of the Bleeding Episode. [ Time Frame: Frame: Through 90 days ± 7days following final OBI-1 dose ]
- Correlation Between the Pre-infusion Anti-OBI-1 Antibody Titers and the Recovery of OBI-1. [ Time Frame: Through 90 days ± 7days following final OBI-1 dose ]
- Recovery and Elimination Rate Parameters of OBI-1 in Subjects With Inhibitors Treated With OBI-1 Therapy. [ Time Frame: Through 90 days ± 7days following final OBI-1 dose ]
- Efficacy Assessment of OBI-1 in Participants With Anti-human Factor VIII Titers >30 Bethesda Units (BU) [ Time Frame: Through 90 days ± 7days following final OBI-1 dose ]
- Anti-human Factor VIII Antibody Titer. [ Time Frame: Through 90 days ± 7days following final OBI-1 dose ]
- Anti-OBI-1 Antibody Titer. [ Time Frame: Through 90 days ± 7days following final OBI-1 dose ]
- Anti-host Cell Protein Baby Hamster Kidney (BHK) Antibody Titer. [ Time Frame: Through 90 days ± 7days following final OBI-1 dose ]
Original Secondary Outcome:
Information By: Baxalta US Inc.
Dates:
Date Received: September 13, 2011
Date Started: August 2011
Date Completion:
Last Updated: June 26, 2015
Last Verified: December 2014