Trial Outcomes & Findings for Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Acquired Hemophilia A (NCT NCT01178294)

Last Updated: 2021-05-13

Results Overview

The initial serious ("qualifying") bleeding episode for each subject was analyzed for the primary efficacy outcome measure. A 'positive response' is defined as 'effective' (bleeding stopped with clinical control and FVIII levels of 50% or higher ) or 'partially effective' (bleeding reduced with clinical stabilization and FVIII levels of 20% or higher) control of bleeding, as determined by the investigator using a 4-point rating scale (effective - partially effective - poorly effective - not effective). 'Poorly effective' is defined as 'bleeding slightly reduced or unchanged and FVIII levels of less than 50%'. 'Not effective' is defined as 'bleeding worsening and FVIII levels of less than 50%'.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

29 participants

Primary outcome timeframe

24 hours after initiation of treatment

Results posted on

2021-05-13

Participant Flow

Enrollment was conducted at 12 clinical sites in 4 countries (USA, Canada, UK, India). Eight sites enrolled subjects under Protocol OBI-1-301 only. Two US sites enrolled subjects under the expanded access protocol OBI-1-301a and subsequently under protocol OBI-1-301. Another 2 US sites enrolled subjects under OBI-1-301a only.

29 subjects were enrolled and all were treated with OBI-1. Data from the expanded access subjects (Protocol 301a, n= 4) are included with the data from subjects enrolled under Protocol OBI-1-301 (n=25). 10 subjects discontinued prematurely and 18 completed the study. For one subject, the completion status could not be verified.

Participant milestones

Participant milestones
Measure	OBI-1 Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
Overall Study STARTED	29
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	OBI-1 Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
Overall Study Adverse Event	4
Overall Study Lost to Follow-up	2
Overall Study Lack of Efficacy	1
Overall Study Death	1
Overall Study Development of inhibitors to OBI-1	1
Overall Study Subject status is terminal	1
Overall Study Completion status could not be verified	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OBI-1 n=29 Participants Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
Age, Continuous	69.8 years STANDARD_DEVIATION 13.28 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Region of Enrollment United States	16 Participants n=5 Participants
Region of Enrollment Canada	5 Participants n=5 Participants
Region of Enrollment United Kingdom	4 Participants n=5 Participants
Region of Enrollment India	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours after initiation of treatment

Population: Intent to Treat (ITT) population = 29 subjects with initial serious bleeding episodes

Outcome measures

Outcome measures
Measure	OBI-1 n=29 Initial Serious Bleeding Episodes Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
Percentage of Serious Bleeding Episodes Responsive to OBI-1	100 percentage of serious bleeding episodes Interval 88.1 to 100.0

SECONDARY outcome

Timeframe: At the time of final treatment dosing (varied from participant to participant depending on bleeding episodes)

Population: ITT population = 29 subjects with initial serious bleeding episodes (BEs)

Treatment success was defined as control of qualifying bleeding episode at the time of final treatment dosing. A serious bleeding episode was considered 'successfully controlled' if the investigator had checked 'completed OBI-1 therapy as treatment success' on the eCRF.

Outcome measures

Outcome measures
Measure	OBI-1 n=29 Initial Serious Bleeding Episodes Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
Overall Percentage of Serious Bleeding Episodes Successfully Controlled With OBI-1 Therapy, as Assessed by the Investigator	86.2 percentage of serious bleeding episodes Interval 68.3 to 96.1

SECONDARY outcome

Timeframe: 8 hours

Population: 21 subjects of the ITT population (n=29) had responses available at 8 hours after initial infusion of OBI-1.

A 'positive response' is defined as 'effective' (bleeding stopped with clinical control and FVIII levels of 50% or higher ) or 'partially effective' (bleeding reduced with clinical stabilization and FVIII levels of 20% or higher) control of bleeding, as determined by the investigator using a 4-point rating scale (effective - partially effective - poorly effective - not effective). 'Poorly effective' is defined as 'bleeding slightly reduced or unchanged and FVIII levels of less than 50%'. 'Not effective' is defined as 'bleeding worsening and FVIII levels of less than 50%'.

Outcome measures

Outcome measures
Measure	OBI-1 n=21 Responses Available at 8 hrs Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
Percentage of Serious Bleeding Episodes Responsive to OBI-1 Therapy at Designated Assessment Time Points After the Initiation of Therapy, as Assessed by the Investigator	95.2 percentage of serious bleeding episodes Interval 76.2 to 99.9

SECONDARY outcome

Timeframe: 16 hours

Population: 19 subjects of the ITT population (n=29) had responses available at 16 hours after initial infusion of OBI-1.

Outcome measures

Outcome measures
Measure	OBI-1 n=19 Responses Available at 16 hrs Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
Percentage of Serious Bleeding Episodes Responsive to OBI-1 Therapy at Designated Assessment Time Points After the Initiation of Therapy, as Assessed by the Investigator	100 percentage of serious bleeding episodes Interval 82.4 to 100.0

SECONDARY outcome

Timeframe: Time of successful control of qualifying bleeding episode (varied from participant to participant)

Population: The analysis was performed in 25 of 29 participants in the ITT population whose 'qualifying' bleeding episode was controlled successfully.

'Frequency of infusions' was calculated as the 'average number of infusions per day'. 'Qualifying bleeding episode' was defined as the 'initial, serious bleeding episode'.

Outcome measures

Outcome measures
Measure	OBI-1 n=25 Participants Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
Frequency of Infusions of OBI-1 Required to Successfully Control Qualifying Bleeding Episodes	2.10 average number of infusions per day Standard Deviation 1.109

SECONDARY outcome

Timeframe: Time of successful control of qualifying bleeding episode (varied from participant to participant)

Population: The analysis was performed in 25 of 29 participants in the ITT population whose 'qualifying' bleeding episode was controlled successfully.

'Qualifying bleeding episode' was defined as the 'initial, serious bleeding episode'.

Outcome measures

Outcome measures
Measure	OBI-1 n=25 Participants Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
Total Dose of OBI-1 Required to Successfully Control 'Qualifying' Bleeding Episodes	2683.2 dose in U/kg Standard Deviation 2928.61

SECONDARY outcome

Timeframe: Time of successful control of qualifying bleeding episode (varied from participant to participant)

Population: The analysis was performed in 25 of 29 participants in the ITT population whose 'qualifying' bleeding episode was controlled successfully.

'Qualifying bleeding episode' was defined as the 'initial, serious bleeding episode'. A serious bleeding episode was considered 'successfully controlled' if the investigator had checked 'completed OBI-1 therapy as treatment success' on the eCRF.

Outcome measures

Outcome measures
Measure	OBI-1 n=25 Participants Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
Total Number of Infusions of OBI-1 Required to Successfully Control 'Qualifying' Bleeding Episodes	15.4 infusions per participant Standard Deviation 12.64

SECONDARY outcome

Timeframe: 24 hours

Population: Of 21 subjects in the ITT population (n=29) with responses available at 8 hours after initial infusion of OBI-1, 20 had a positive response.

Outcome measures

Outcome measures
Measure	OBI-1 n=21 Participants Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
Correlation Between Positive Response to OBI-1 Therapy at 8 Hours and Eventual Control of Serious Bleeding Episodes at 24 Hours	17 subjects with eventual bleed control

SECONDARY outcome

Timeframe: 24 hours

Population: All 19 subjects in the ITT population (n=29) who had responses available at 16 hours after initial infusion of OBI-1 had a positive response.

Outcome measures

Outcome measures
Measure	OBI-1 n=19 Participants Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
Correlation Between Response to OBI-1 Therapy at 16 Hours and Eventual Control of Serious Bleeding Episodes at 24 Hours	17 subjects with eventual bleed control

SECONDARY outcome

Timeframe: 24 hours

Population: 29 subjects (ITT population) had responses available at 24 hours after initial infusion of OBI-1.

Outcome measures

Outcome measures
Measure	OBI-1 n=29 Participants Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
Correlation Between Response to OBI-1 Therapy at Specified Time Points and Eventual Control of Serious Bleeding Episodes at 24 Hours	25 participants with bleeds controlled

SECONDARY outcome

Population: 28 eligible subjects with acquired hemophilia A in the ITT population (n=29), of whom 18 had no detectable anti-porcine FVIII inhibitor titers at baseline (\<0.6 BU) and 10 had detectable anti-porcine FVIII antibody titers at baseline (\>=0.6 BU)

Outcome measures

Outcome measures
Measure	OBI-1 n=28 Participants Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
Number of Participants Who Developed de Novo Anti-OBI-1 Antibody Titers	5 participants

SECONDARY outcome

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

Population: 21 subjects in the ITT population (n=29) with available baseline and follow-up test results

Outcome measures

Outcome measures
Measure	OBI-1 n=21 Participants Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
Number of Participants Who Developed an Anti-host Cell Protein Baby Hamster Kidney (BHK) Antibody Titer	0 participants

OTHER_PRE_SPECIFIED outcome

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

Population: Anti-human factor VIII antibody titer data were presented in subject data listings. No statistical test was planned for anti-human factor VIII antibody titer.

Outcome measures

Outcome data not reported

Adverse Events

OBI-1

Serious events: 13 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	OBI-1 n=29 participants at risk Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
General disorders Asthenia	3.4% 1/29 • Number of events 1 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Nervous system disorders Dizziness	3.4% 1/29 • Number of events 1 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Vascular disorders Hematoma	3.4% 1/29 • Number of events 2 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Cardiac disorders Atrial fibrillation	3.4% 1/29 • Number of events 1 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Infections and infestations Pneumonia	10.3% 3/29 • Number of events 3 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Infections and infestations Sepsis	6.9% 2/29 • Number of events 2 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Nervous system disorders Brain edema	3.4% 1/29 • Number of events 1 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Nervous system disorders Intracranial hemorrhage	6.9% 2/29 • Number of events 2 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Nervous system disorders Transient ischemic attack	3.4% 1/29 • Number of events 1 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Gastrointestinal disorders Esophagitis	3.4% 1/29 • Number of events 1 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Renal and urinary disorders Renal failure	3.4% 1/29 • Number of events 1 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Infections and infestations Systemic mycosis	3.4% 1/29 • Number of events 1 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Infections and infestations Urinary tract infection	3.4% 1/29 • Number of events 1 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Gastrointestinal disorders Gastrointestinal hemorrhage	3.4% 1/29 • Number of events 1 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Musculoskeletal and connective tissue disorders Arthralgia	3.4% 1/29 • Number of events 3 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Musculoskeletal and connective tissue disorders Joint swelling	3.4% 1/29 • Number of events 2 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Hepatobiliary disorders Cholangitis	3.4% 1/29 • Number of events 1 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.4% 1/29 • Number of events 1 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Immune system disorders Anaphylactic reaction	3.4% 1/29 • Number of events 1 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Musculoskeletal and connective tissue disorders Hemarthrosis	3.4% 1/29 • Number of events 1 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Gastrointestinal disorders Intestinal hemorrhage	3.4% 1/29 • Number of events 1 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Injury, poisoning and procedural complications Fall	3.4% 1/29 • Number of events 1 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Injury, poisoning and procedural complications Tracheostomy malfunction	3.4% 1/29 • Number of events 1 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	3.4% 1/29 • Number of events 1 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Nervous system disorders Grand mal convulsion	3.4% 1/29 • Number of events 1 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.

Other adverse events

Other adverse events
Measure	OBI-1 n=29 participants at risk Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
Blood and lymphatic system disorders Anemia	20.7% 6/29 • Number of events 6 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Cardiac disorders Cardiac failure congestive	6.9% 2/29 • Number of events 2 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Gastrointestinal disorders Abdominal pain	6.9% 2/29 • Number of events 3 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Gastrointestinal disorders Abdominal pain upper	6.9% 2/29 • Number of events 3 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Gastrointestinal disorders Constipation	41.4% 12/29 • Number of events 12 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Gastrointestinal disorders Diarrhea	24.1% 7/29 • Number of events 7 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Gastrointestinal disorders Mouth ulceration	6.9% 2/29 • Number of events 2 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Gastrointestinal disorders Nausea	13.8% 4/29 • Number of events 5 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Gastrointestinal disorders Vomiting	6.9% 2/29 • Number of events 2 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
General disorders Chest pain	6.9% 2/29 • Number of events 2 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
General disorders Fatigue	6.9% 2/29 • Number of events 2 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
General disorders Peripheral edema	20.7% 6/29 • Number of events 7 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
General disorders Pyrexia	10.3% 3/29 • Number of events 5 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Infections and infestations Bacteremia	6.9% 2/29 • Number of events 2 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Infections and infestations Bacteriuria	6.9% 2/29 • Number of events 2 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Infections and infestations Candidiasis	10.3% 3/29 • Number of events 3 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Infections and infestations Sepsis	10.3% 3/29 • Number of events 3 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Infections and infestations Oral candidiasis	10.3% 3/29 • Number of events 3 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Infections and infestations Urinary tract infection	6.9% 2/29 • Number of events 2 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Investigations Antibody test positive	6.9% 2/29 • Number of events 2 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Investigations Troponin I increased	6.9% 2/29 • Number of events 2 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Metabolism and nutrition disorders Decreased appetite	10.3% 3/29 • Number of events 3 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Metabolism and nutrition disorders Hypoglycemia	6.9% 2/29 • Number of events 2 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Metabolism and nutrition disorders Hypokalemia	24.1% 7/29 • Number of events 11 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Metabolism and nutrition disorders Hypomagnesemia	6.9% 2/29 • Number of events 2 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Metabolism and nutrition disorders Hypophosphatemia	6.9% 2/29 • Number of events 2 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Musculoskeletal and connective tissue disorders Muscle hemorrhage	6.9% 2/29 • Number of events 3 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Musculoskeletal and connective tissue disorders Pain in extremity	6.9% 2/29 • Number of events 2 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Psychiatric disorders Depression	6.9% 2/29 • Number of events 2 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Psychiatric disorders Insomnia	13.8% 4/29 • Number of events 6 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Respiratory, thoracic and mediastinal disorders Wheezing	6.9% 2/29 • Number of events 3 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Skin and subcutaneous tissue disorders Ecchymosis	10.3% 3/29 • Number of events 3 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Skin and subcutaneous tissue disorders Pruritus	6.9% 2/29 • Number of events 2 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Vascular disorders Hypertension	10.3% 3/29 • Number of events 4 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.
Vascular disorders Hypotension	6.9% 2/29 • Number of events 2 • Through 90 days ± 7 days following final OBI-1 dose Subjects were monitored for adverse events from the time the subject presented with the initial bleeding episode until the end of the follow-up period.

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee For this study, PIs are restricted from independently publishing results before completion of a single multicenter publication or one year after study completion, whichever occurs first. Baxter requires a review of results communications (eg, for confidential information) ≥30 days prior to submission or communication. Baxter may request an additional delay of ≤60 days (eg, if a patentable invention is disclosed).
Publication restrictions are in place

Restriction type: OTHER