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Trial record 35 of 404 for:    bleeding episodes

Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Congenital Hemophilia A

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01434511
Recruitment Status : Terminated
First Posted : September 15, 2011
Results First Posted : December 17, 2014
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Shire ( Baxalta now part of Shire )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hemophilia A
Intervention Biological: OBI-1
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title OBI-1
Hide Arm/Group Description OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title OBI-1
Hide Arm/Group Description OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
Overall Number of Baseline Participants 0
Hide Baseline Analysis Population Description
This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).
Age, Continuous   [1] 
Unit of measure:  Years
Number Analyzed 0 participants
[1]
Measure Description: This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).
Sex: Female, Male   [1] 
Number Analyzed 0 participants
Female
Male
[1]
Measure Description: This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).
Region of Enrollment   [1] 
Unit of measure:  Participants
United States Number Analyzed 0 participants
[1]
Measure Description: This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).
1.Primary Outcome
Title Proportion of Serious Bleeding Episodes Responsive to OBI-1
Hide Description This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, the study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within the OBI-1-302 study (Congenital Hemophilia A).
Time Frame 24 hours after initiation of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).
Arm/Group Title OBI-1
Hide Arm/Group Description:
OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Overall Proportion of Serious Bleeding Episodes Successfully Controlled With OBI-1 Therapy, as Assessed by the Investigator.
Hide Description [Not Specified]
Time Frame Through 90 days ± 7days following final OBI-1 dose
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).
Arm/Group Title OBI-1
Hide Arm/Group Description:
OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Proportion of Bleeding Episodes Responsive to OBI-1 Therapy at Designated Assessment Time Points After the Initiation of Therapy, as Assessed by the Investigator
Hide Description [Not Specified]
Time Frame Through 90 days ± 7days following final OBI-1 dose
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).
Arm/Group Title OBI-1
Hide Arm/Group Description:
OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Frequency of Infusions of OBI-1 Required to Successfully Control Qualifying Bleeding Episodes.
Hide Description [Not Specified]
Time Frame Through 90 days ± 7days following final OBI-1 dose
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).
Arm/Group Title OBI-1
Hide Arm/Group Description:
OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Total Dose of OBI-1 Required to Successfully Control Qualifying Bleeding Episodes.
Hide Description [Not Specified]
Time Frame Through 90 days ± 7days following final OBI-1 dose
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).
Arm/Group Title OBI-1
Hide Arm/Group Description:
OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Total Number of Infusions of OBI-1 Required to Successfully Control Qualifying Bleeding Episodes.
Hide Description [Not Specified]
Time Frame Through 90 days ± 7days following final OBI-1 dose
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).
Arm/Group Title OBI-1
Hide Arm/Group Description:
OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Correlation Between Response to OBI-1 Therapy at Specified Time Points and Eventual Control of Serious Bleeding Episodes.
Hide Description [Not Specified]
Time Frame Through 90 days ± 7days following final OBI-1 dose
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).
Arm/Group Title OBI-1
Hide Arm/Group Description:
OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame Frame: Through 90 days ± 7days following final OBI-1 dose
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).
Arm/Group Title OBI-1
Hide Arm/Group Description:
OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Correlation Between the Pre-infusion Anti-OBI-1 Antibody Titers and the Recovery of OBI-1.
Hide Description [Not Specified]
Time Frame Through 90 days ± 7days following final OBI-1 dose
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).
Arm/Group Title OBI-1
Hide Arm/Group Description:
OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Recovery and Elimination Rate Parameters of OBI-1 in Subjects With Inhibitors Treated With OBI-1 Therapy.
Hide Description [Not Specified]
Time Frame Through 90 days ± 7days following final OBI-1 dose
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).
Arm/Group Title OBI-1
Hide Arm/Group Description:
OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Efficacy Assessment of OBI-1 in Participants With Anti-human Factor VIII Titers >30 Bethesda Units (BU)
Hide Description [Not Specified]
Time Frame Through 90 days ± 7days following final OBI-1 dose
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).
Arm/Group Title OBI-1
Hide Arm/Group Description:
OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Anti-human Factor VIII Antibody Titer.
Hide Description [Not Specified]
Time Frame Through 90 days ± 7days following final OBI-1 dose
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).
Arm/Group Title OBI-1
Hide Arm/Group Description:
OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Anti-OBI-1 Antibody Titer.
Hide Description [Not Specified]
Time Frame Through 90 days ± 7days following final OBI-1 dose
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).
Arm/Group Title OBI-1
Hide Arm/Group Description:
OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Anti-host Cell Protein Baby Hamster Kidney (BHK) Antibody Titer.
Hide Description [Not Specified]
Time Frame Through 90 days ± 7days following final OBI-1 dose
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).
Arm/Group Title OBI-1
Hide Arm/Group Description:
OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title OBI-1
Hide Arm/Group Description OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
All-Cause Mortality
OBI-1
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
OBI-1
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
OBI-1
Affected / at Risk (%)
Total   0/1 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Baxter's agreements with PIs may vary per requirements of individual PI, but contain common elements. For this study, PIs are restricted from independently publishing results until the earlier of the primary multicenter publication or 12 months after study completion. Baxter requires a review of results communications (e.g., for confidential information) ≥30 days prior to submission or communication. Baxter may request an additional delay of ≤30 days(e.g., for intellectual property protection)
Results Point of Contact
Name/Title: Heinrich Farin, MD
Organization: Baxter Healthcare Corporation
Responsible Party: Shire ( Baxalta now part of Shire )
ClinicalTrials.gov Identifier: NCT01434511     History of Changes
Other Study ID Numbers: OBI-1-302
First Submitted: September 13, 2011
First Posted: September 15, 2011
Results First Submitted: December 11, 2014
Results First Posted: December 17, 2014
Last Update Posted: November 24, 2017