Trial Outcomes & Findings for BAX 802 in CHA With Inhibitors (NCT NCT02895945)

Results Overview

GHEA score consisted of 3 individual rating scales: (1) Intra-operative Efficacy Assessment Scale, (2) Post-operative Efficacy Assessment Scale, and (3) Overall Peri-operative Efficacy Assessment Scale. Scales 1 and 2 was performed by the operating surgeon on Day 1, and Scale 3 was performed by the investigator on Day 14. Each rating scale was based on 4 points scale ranging from: 3 (Excellent), 2 (Good), 1 (Fair), and 0 (None). Total score ranged from 0 to 9, where scores evaluated as: excellent (7 to 9), good (5 to 7), fair (3 to 4), and none (0 to 2). The scores of 3 individual ratings scales were added together to form a GHEA score. For a GHEA score of 7 to be rated "excellent" with no individual assessment scores less than (\<) 2 and at least 1 assessment score equal to (=) 3; otherwise a score of 7 was rated "good". Percentage of Surgeries With a "Good" or "Excellent" response as measured by the GHEA score were reported.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

8 participants

Primary outcome timeframe

Day 1 up to discharge or Day 14 (whichever was earlier)

Results posted on

2021-10-20

Participant Flow

This study was conducted at 5 sites in Italy, Netherlands, Poland, Germany and Turkey. Study was initiated on 22 December 2016 and terminated on 22 January 2021.

A total of 8 participants planned for Major Surgeries and Minor Surgeries received recombinant porcine factor VIII (rpFVIII) (BAX 802).

Participant milestones

Participant milestones
Measure	Major Surgeries Male participants with congenital hemophilia A (CHA) with inhibitors to human factor VIII (hFVIII) undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target factor VIII (FVIII) level of greater than or equal to (\>=) 80 percent (%) approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Minor Surgeries Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of \>=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Overall Study STARTED	7	1
Overall Study SAS	7	1
Overall Study FAS	7	0
Overall Study COMPLETED	5	0
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Major Surgeries Male participants with congenital hemophilia A (CHA) with inhibitors to human factor VIII (hFVIII) undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target factor VIII (FVIII) level of greater than or equal to (\>=) 80 percent (%) approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Minor Surgeries Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of \>=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Overall Study Physician Decision	2	1

Baseline Characteristics

BAX 802 in CHA With Inhibitors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Major Surgeries n=7 Participants Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of \>=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Minor Surgeries n=1 Participants Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of \>=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Total n=8 Participants Total of all reporting groups
Age, Continuous	35.9 years STANDARD_DEVIATION 14.39 • n=5 Participants	58.0 years n=7 Participants	38.6 years STANDARD_DEVIATION 15.45 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 up to discharge or Day 14 (whichever was earlier)

Population: Full analysis set (FAS) comprised of all participants with at least one available hemostatic assessment.

GHEA score consisted of 3 individual rating scales: (1) Intra-operative Efficacy Assessment Scale, (2) Post-operative Efficacy Assessment Scale, and (3) Overall Peri-operative Efficacy Assessment Scale. Scales 1 and 2 was performed by the operating surgeon on Day 1, and Scale 3 was performed by the investigator on Day 14. Each rating scale was based on 4 points scale ranging from: 3 (Excellent), 2 (Good), 1 (Fair), and 0 (None). Total score ranged from 0 to 9, where scores evaluated as: excellent (7 to 9), good (5 to 7), fair (3 to 4), and none (0 to 2). The scores of 3 individual ratings scales were added together to form a GHEA score. For a GHEA score of 7 to be rated "excellent" with no individual assessment scores less than (\<) 2 and at least 1 assessment score equal to (=) 3; otherwise a score of 7 was rated "good". Percentage of Surgeries With a "Good" or "Excellent" response as measured by the GHEA score were reported.

Outcome measures

Outcome measures
Measure	Major Surgeries n=7 surgeries Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of \>=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Minor Surgeries Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of \>=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Percentage of Surgeries With a "Good" or "Excellent" Response as Measured by the Global Hemostatic Efficacy Assessment (GHEA) Score GHEA rating: Good	14.3 percentage of surgeries	—
Percentage of Surgeries With a "Good" or "Excellent" Response as Measured by the Global Hemostatic Efficacy Assessment (GHEA) Score GHEA rating: Excellent	71.4 percentage of surgeries	—

SECONDARY outcome

Timeframe: Intra-operative: up to completion of surgery (Day 1), Post-operative: at 24 hours post-surgery, and Peri-operative: at discharge or Day 14 (whichever was earlier)

Population: FAS comprised of all participants with at least one available hemostatic assessment. Here "number analyzed" were participants who were evaluable for the outcome measure at given categories.

Prior to the surgery, the surgeon/investigator predicted and compared the estimated volume (in milliliter \[mL\]) of the expected average blood loss and expected maximum blood loss for the planned surgical intervention in a comparable healthy individual with similar demographic characteristics; for intraoperative, postoperative, and overall perioperative time periods. Intra-operative defined as period from start of surgery to completion of surgical procedure. Post-operative defined as period from completion of surgical procedure till 24 hours post-surgery. Peri-operative defined as period from start of surgical procedure till discharge or 14 days post surgery (whichever was earlier). Actual blood loss, estimated volume of expected average blood loss and expected maximum blood loss during each operative period was reported.

Outcome measures

Outcome measures
Measure	Major Surgeries n=7 surgeries Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of \>=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Minor Surgeries Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of \>=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Actual Blood Loss, Estimated Volume of Expected Average Blood Loss and Expected Maximum Blood Loss During Intra-operative, Post-operative and Peri-operative Period Intra-operative Period: Actual Blood Loss	141.1 milliliter (mL) Standard Deviation 188.69	—
Actual Blood Loss, Estimated Volume of Expected Average Blood Loss and Expected Maximum Blood Loss During Intra-operative, Post-operative and Peri-operative Period Intra-operative Period: Expected Average Blood Loss	221.7 milliliter (mL) Standard Deviation 286.76	—
Actual Blood Loss, Estimated Volume of Expected Average Blood Loss and Expected Maximum Blood Loss During Intra-operative, Post-operative and Peri-operative Period Intra-operative Period: Expected Maximum Blood Loss	414.7 milliliter (mL) Standard Deviation 546.37	—
Actual Blood Loss, Estimated Volume of Expected Average Blood Loss and Expected Maximum Blood Loss During Intra-operative, Post-operative and Peri-operative Period Post-operative Period: Actual Blood Loss	31.0 milliliter (mL) Standard Deviation 66.56	—
Actual Blood Loss, Estimated Volume of Expected Average Blood Loss and Expected Maximum Blood Loss During Intra-operative, Post-operative and Peri-operative Period Post-operative Period: Expected Average Blood Loss	171.4 milliliter (mL) Standard Deviation 276.17	—
Actual Blood Loss, Estimated Volume of Expected Average Blood Loss and Expected Maximum Blood Loss During Intra-operative, Post-operative and Peri-operative Period Post-operative Period: Expected Maximum Blood Loss	378.0 milliliter (mL) Standard Deviation 570.94	—
Actual Blood Loss, Estimated Volume of Expected Average Blood Loss and Expected Maximum Blood Loss During Intra-operative, Post-operative and Peri-operative Period Peri-operative Period: Actual Blood Loss	164.1 milliliter (mL) Standard Deviation 215.15	—
Actual Blood Loss, Estimated Volume of Expected Average Blood Loss and Expected Maximum Blood Loss During Intra-operative, Post-operative and Peri-operative Period Peri-operative Period: Expected Average Blood Loss	465.0 milliliter (mL) Standard Deviation 744.85	—
Actual Blood Loss, Estimated Volume of Expected Average Blood Loss and Expected Maximum Blood Loss During Intra-operative, Post-operative and Peri-operative Period Peri-operative Period: Expected Maximum Blood Loss	842.9 milliliter (mL) Standard Deviation 1310.01	—

SECONDARY outcome

Timeframe: Intra-operative: up to completion of surgery (Day 1), Post-operative: at 24 hours post-surgery, and Peri-operative: at discharge or Day 14 (whichever was earlier)

Population: FAS comprised of all participants with at least one available hemostatic assessment. Here "number analyzed" were participants who were evaluable for the outcome measure at given categories.

Prior to the surgery, the surgeon/investigator predicted and compared the estimated volume (mL) of the expected average blood loss and expected maximum blood loss for the planned surgical intervention in a comparable healthy individual with similar demographic characteristics; for intraoperative, postoperative, and overall perioperative time periods. Intra-operative defined as period from start of surgery to completion of surgical procedure. Post-operative defined as period from completion of surgical procedure till 24 hours post-surgery. Peri-operative defined as period from start of surgical procedure till discharge or 14 days post surgery (whichever was earlier). Ratio of actual blood loss and estimated volume of expected average blood loss during each operative period was reported.

Outcome measures

Outcome measures
Measure	Major Surgeries n=7 surgeries Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of \>=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Minor Surgeries Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of \>=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Ratio of Actual Blood Loss and Estimated Volume of Expected Average Blood Loss During Intra-operative, Post-operative and Peri-operative Period Intra-operative Period	0.970 ratio Standard Deviation 0.9486	—
Ratio of Actual Blood Loss and Estimated Volume of Expected Average Blood Loss During Intra-operative, Post-operative and Peri-operative Period Post-operative Period	0.150 ratio Standard Deviation 0.2236	—
Ratio of Actual Blood Loss and Estimated Volume of Expected Average Blood Loss During Intra-operative, Post-operative and Peri-operative Period Peri-operative Period	0.545 ratio Standard Deviation 0.3448	—

SECONDARY outcome

Timeframe: Intra-operative: up to completion of surgery (Day 1), Post-operative: at 24 hours post-surgery, and Peri-operative: at discharge or Day 14 (whichever was earlier)

Population: FAS comprised of all participants with at least one available hemostatic assessment. Here "number analyzed" were participants who were evaluable for the outcome measure at given categories.

Prior to the surgery, the surgeon/investigator predicted and compared the estimated volume (mL) of the expected average blood loss and expected maximum blood loss for the planned surgical intervention in a comparable healthy individual with similar demographic characteristics; for intraoperative, postoperative, and overall perioperative time periods. Intra-operative defined as period from start of surgery to completion of surgical procedure. Post-operative defined as period from completion of surgical procedure till 24 hours post-surgery. Peri-operative defined as period from start of surgical procedure till discharge or 14 days post surgery (whichever was earlier). Ratio of actual blood loss and expected maximum blood loss during each operative period was reported.

Outcome measures

Outcome measures
Measure	Major Surgeries n=7 surgeries Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of \>=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Minor Surgeries Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of \>=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Ratio of Actual Blood Loss and Expected Maximum Blood Loss During Intra-operative, Post-operative and Peri-operative Period Intra-operative Period	0.555 ratio Standard Deviation 0.6517	—
Ratio of Actual Blood Loss and Expected Maximum Blood Loss During Intra-operative, Post-operative and Peri-operative Period Post-operative Period	0.058 ratio Standard Deviation 0.0846	—
Ratio of Actual Blood Loss and Expected Maximum Blood Loss During Intra-operative, Post-operative and Peri-operative Period Peri-operative Period	0.306 ratio Standard Deviation 0.1962	—

SECONDARY outcome

Timeframe: Day 1 up to discharge or Day 14 (whichever was earlier)

Population: FAS comprised of all participants with at least one available hemostatic assessment. As planned, this outcome measure was only analyzed for major surgeries. There were 7 participants analyzed for major surgeries and all the 7 participants underwent 7 surgeries.

Percentage of major surgeries with good or excellent hemostatic score was analyzed by GHEA score. It consisted of 3 individual ratings: (1) Intra-operative Efficacy Assessment Scale, (2) Post-operative Efficacy Assessment Scale, (3) Postoperative Efficacy Assessment Scale. Ratings 1 and 2 was performed by the operating surgeon on Day 1, and Rating 3 was performed by the investigator on Day 14. Each rating scale was based on 4 point scale ranging from: 3 (Excellent), 2 (Good), 1 (Fair), and 0 (None). The scores of each of the 3 individual ratings scales, was added together to form a GHEA score. Total score ranged from 0 to 9 where scores evaluated as excellent (7 to 9), good (5 to 7), fair (3 to 4), and none (0 to 2). Hemostatic efficacy success was defined as "excellent" or "good "outcome for \>=70% of hemostatic efficacy assessments. Percentage of major surgeries with good or excellent hemostatic score were reported.

Outcome measures

Outcome measures
Measure	Major Surgeries n=7 surgeries Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of \>=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Minor Surgeries Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of \>=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Percentage of Major Surgeries With Good or Excellent Hemostatic Score	85.7 percentage of surgeries Interval 42.1 to 99.6	—

SECONDARY outcome

Timeframe: Pre-operative: before surgery, Intra-operative: up to completion of surgery (Day 1), Post-operative: from completion of surgical procedure till discharge or 14 days post surgery (whichever was earlier)

Population: SAS comprised of all participants who received any amount of BAX 802. Here "number analyzed" were participants who were evaluable for the outcome measure at given categories.

Body-weight adjusted dose equals to amount infused/body-weight (kilogram \[kg\]), where amount infused as amount of drug infused (International Units \[IU\]) and body-weight as the last available body-weight (kg) prior to the infusion. Pre-operative defined as period prior to surgery. Intra-operative defined as period from start of surgery to completion of surgical procedure. Post-operative defined as period from completion of surgical procedure till discharge or 14 days post surgery (whichever was earlier). Average daily weight-adjusted dose of BAX 802 per participant during each operative period was reported.

Outcome measures

Outcome measures
Measure	Major Surgeries n=7 Participants Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of \>=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Minor Surgeries n=1 Participants Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of \>=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Average Daily Weight-adjusted Dose of BAX 802 Per Participant During Pre-operative, Intra-operative and Post-operative Period Pre-operative	162.471 International Units per kilogram (IU/kg) Standard Deviation 125.7051	208.779 International Units per kilogram (IU/kg)
Average Daily Weight-adjusted Dose of BAX 802 Per Participant During Pre-operative, Intra-operative and Post-operative Period Intra-operative	76.083 International Units per kilogram (IU/kg) Standard Deviation 35.1339	—
Average Daily Weight-adjusted Dose of BAX 802 Per Participant During Pre-operative, Intra-operative and Post-operative Period Post-operative	43.549 International Units per kilogram (IU/kg) Standard Deviation 56.0039	—

SECONDARY outcome

Timeframe: Pre-operative: before surgery, Intra-operative: up to completion of surgery (Day 1), Post-operative: from completion of surgical procedure till discharge or 14 days post surgery (whichever was earlier)

Population: SAS comprised of all participants who received any amount of BAX 802. Here "number analyzed" were participants who were evaluable for the outcome measure at given categories.

Body-weight adjusted dose equals to amount infused/body-weight (kg), where amount infused as amount of drug infused (IU) and body-weight as the last available body-weight (kg) prior to the infusion. Pre-operative defined as period prior to surgery. Intra-operative defined as period from start of surgery to completion of surgical procedure. Post-operative defined as period from completion of surgical procedure till discharge or 14 days post surgery (whichever was earlier). Total weight-adjusted dose of BAX 802 per participant during each operative period was reported.

Outcome measures

Outcome measures
Measure	Major Surgeries n=7 Participants Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of \>=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Minor Surgeries n=1 Participants Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of \>=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Total Weight-adjusted Dose of BAX 802 Per Participant During Pre-operative, Intra-operative and Post-operative Period Pre-operative	162.471 IU/kg Standard Deviation 125.7051	208.779 IU/kg
Total Weight-adjusted Dose of BAX 802 Per Participant During Pre-operative, Intra-operative and Post-operative Period Intra-operative	76.083 IU/kg Standard Deviation 35.1339	—
Total Weight-adjusted Dose of BAX 802 Per Participant During Pre-operative, Intra-operative and Post-operative Period Post-operative	625.520 IU/kg Standard Deviation 399.4913	—

SECONDARY outcome

Timeframe: From initiation of the surgery up to discharge or Day 14 (whichever came earlier)

Population: FAS comprised of all participants with at least one available hemostatic assessment. Here "overall number of participants analyzed" were participants who were evaluable for this outcome measure.

The volume (in mL) of blood products transfused from initiation of the intervention to discharge or Day 14 (whichever came earlier) was reported.

Outcome measures

Outcome measures
Measure	Major Surgeries n=2 Participants Male participants with CHA with inhibitors to hFVIII undergone major surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of \>=80% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.	Minor Surgeries Male participants with CHA with inhibitors to hFVIII undergone minor surgical invasive procedures initially received loading dose BAX 802 infusion, intravenously to maintain a minimum target FVIII level of \>=50% approximately 1 to 2 hours prior to the surgery. Subsequent dosing was based on participant's FVIII activity levels, body weight and investigator's clinical judgement.
Volume of Blood Products Transfused	950.0 mL Standard Deviation 70.71	—

SECONDARY outcome

Timeframe: Baseline up end of study (EOS) (up to 44 months)

Population: SAS comprised of all participants who received any amount of BAX 802.

De novo inhibitor was defined as a post-baseline inhibitor titer to FVIII (hFVIII or porcine factor VIII \[pFVIII\])of \>=0.6 Bethesda units per milliliter (BU/mL) given a baseline of \<0.6 BU/mL. Number of participants with de novo inhibitors were reported.