Trial Outcomes & Findings for Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Congenital Hemophilia A (NCT NCT01434511)

Results Overview

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).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

1 participants

Primary outcome timeframe

24 hours after initiation of treatment

Results posted on

2021-05-14

Participant Flow

Participant milestones

Participant milestones
Measure	OBI-1 OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 24 hours after initiation of treatment

Population: 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).

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 90 days ± 7days following final OBI-1 dose

Population: 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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 90 days ± 7days following final OBI-1 dose

Population: 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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 90 days ± 7days following final OBI-1 dose

Population: 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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 90 days ± 7days following final OBI-1 dose

Population: 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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 90 days ± 7days following final OBI-1 dose

Population: 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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 90 days ± 7days following final OBI-1 dose

Population: 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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Frame: Through 90 days ± 7days following final OBI-1 dose

Population: 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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 90 days ± 7days following final OBI-1 dose

Population: 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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 90 days ± 7days following final OBI-1 dose

Population: 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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 90 days ± 7days following final OBI-1 dose

Population: 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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 90 days ± 7days following final OBI-1 dose

Population: 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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 90 days ± 7days following final OBI-1 dose

Population: 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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 90 days ± 7days following final OBI-1 dose

Population: 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).

Outcome measures

Outcome data not reported

Adverse Events

OBI-1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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)
Publication restrictions are in place

Restriction type: OTHER