BAX 855 PK-guided Dosing | NCT02585960

ID	Type	Description	Link
2014-005477-37	EudraCT Number

Name	Class
Baxalta Innovations GmbH, now part of Shire	INDUSTRY

Label	Type	Description	Intervention Names
Pharmacokinetic (PK) evaluation of BAX 855	Experimental	Participants will first undergo an initial pharmacokinetic (PK) assessment. Following the PK assessment participants will be randomized to one of 2 dosing regimens.	Biological: PEGylated Recombinant Factor VIII
FVIII trough target 1-3%	Experimental	Standard treatment arm - PK-guided dosing schedule to achieve a Factor VIII (FVIII) trough of 1-3%	Biological: PEGylated Recombinant Factor VIII
FVIII trough target 8-12%	Experimental	Intensified treatment arm - PK-guided dosing schedule to achieve a Factor VIII (FVIII) trough of 8-12%	Biological: PEGylated Recombinant Factor VIII

Name	Type	Description	Arm Group Labels	Other Names
PEGylated Recombinant Factor VIII	Biological	Pharmacokinetic (PK) evaluation	Pharmacokinetic (PK) evaluation of BAX 855

Measure	Description	Time Frame
Percentage of Participants With a Total Annualized Bleeding Rate (ABR) of Zero for Second Six Months	Annualized bleeding rate was determined by dividing the number of bleeds by observation period in years.	Day 183 to Day 364 (6 months)

Measure	Description	Time Frame
Total Annualized Bleeding Rate for Second Six Months	Annualized bleeding rate was determined by dividing the number of bleeds by observation period in years.	Day 183 to Day 364 (6 months)
Annualized Spontaneous Bleeding Rate for Second Six Months

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA:

Participants transitioning from another BAX 855 study who meet ALL of the following criteria are eligible for this study:
1. Participant has completed the end of study visit of a BAX 855 study or is transitioning from the ongoing Baxalta Continuation Study 261302.
2. Participant is either receiving on-demand treatment or prophylactic treatment with BAX 855 and had an Annual Bleed Rate (ABR) of ≥ 2 documented and treated during the past 12 months.
3. Participant is human immunodeficiency virus negative (HIV-); or HIV+ with stable disease and CD4+ count ≥ 200 cells/mm^3, as confirmed by central laboratory.
4. Participant is willing and able to comply with the requirements of the protocol.
Newly recruited participants (ie not transitioning from another BAX 855 study) including BAX855 naïve participants who meet ALL of the following criteria are eligible for this study:
1. Participant has severe hemophilia A (FVIII clotting activity < 1%) as confirmed by central laboratory OR by historically documented FVIII clotting activity performed by a certified clinical laboratory, optionally supported by a FVIII gene mutation consistent with severe hemophilia A
2. Participant has been previously treated with plasma-derived FVIII concentrates or recombinant FVIII for ≥ 150 documented exposure days (EDs)
3. Participant is either receiving on-demand treatment or prophylactic treatment and had an annual bleeding rate of ≥ 2 documented and treated during the past 12 months.
4. Participant has a Karnofsky performance score of ≥ 60 at screening
5. Participant is HIV-; or HIV+ with stable disease and CD4+ count ≥ 200 cells/mm^3, as confirmed by central laboratory at screening
6. Participant is hepatitis C virus negative (HCV-) by antibody (if positive, additional PCR testing will be performed), as confirmed by central laboratory at screening; or HCV+ with chronic stable hepatitis
7. If female of childbearing potential, participant presents with a negative urine pregnancy test and agrees to employ adequate birth control measures for the duration of the study
8. Participant is willing and able to comply with the requirements of the protocol.

EXCLUSION CRITERIA:

Participants transitioning from another BAX 855 study who meet ANY of the following criteria are not eligible for this study:
1. Participant has developed a confirmed inhibitory antibody to FVIII with a titer of ≥ 0.6 BU using the Nijmegen modification of the Bethesda assay as determined at the central laboratory during the course of the previous BAX 855 study.
2. Participant has been diagnosed with an acquired hemostatic defect other than hemophilia A.
3. The participant's weight is < 35 kg or > 100 kg.
4. Participant's platelet count is < 100,000/mL.
5. Participant has an abnormal renal function (serum creatinine > 1.5 times the upper limit of normal).
6. Participant has active hepatic disease with alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels ≥ 5 times the upper limit of normal.
7. Participant is scheduled to receive a systemic immunomodulating drug (e.g. corticosteroid agents at a dose equivalent to hydrocortisone greater than 10 mg/day, or α-interferon) other than anti-retroviral chemotherapy during the study.
8. Participant has a clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect participant's safety or compliance.
9. Participant is planning to take part in any other clinical study during the course of the study.
10. Participant is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie, children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study.

Newly recruited participants (ie not transitioning from another BAX 855 study) who meet ANY of the following criteria are not eligible for this study:

Participant has detectable FVIII inhibitory antibodies (≥ 0.6 BU using the Nijmegen modification of the Bethesda assay) as confirmed by central laboratory at screening.
Participant has a history of confirmed FVIII inhibitors with a titer ≥ 0.6 Bethesda Units (BU) (as determined by the Nijmegen modification of the Bethesda assay or the assay employed with the respective cut-off in the local laboratory) at any time prior to screening.
Participant has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia A (eg, qualitative platelet defect or von Willebrand's disease).
The participant's weight is < 35 kg or > 100 kg.
Participant's platelet count is < 100,000/mL.
Participant has known hypersensitivity towards mouse or hamster proteins, PEG or Tween 80.
Participant has severe chronic hepatic dysfunction [eg, ≥ 5 times upper limit of normal alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST), as confirmed by central laboratory at screening, or a documented INR > 1.5].
Participant has severe renal impairment (serum creatinine > 1.5 times the upper limit of normal).
Participant has current or recent (< 30 days) use of other pegylated drugs prior to study participation or is scheduled to use such drugs during study participation.
Participant is scheduled to receive during the course of the study, a systemic immunomodulating drug (e.g. corticosteroid agents at a dose equivalent to hydrocortisone greater than 10 mg/day, or α-interferon) other than anti-retroviral chemotherapy.
Participant has participated in another clinical study involving an IP or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.
Participant has a medical, psychiatric, or cognitive illness or recreational drug/alcohol use that, in the opinion of the investigator, would affect participant safety or compliance.
Participant is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie, children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study.

Name	Affiliation	Role
Study Director	Takeda	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Phoenix Childrens Hospital		Phoenix	Arizona	85016-7710	United States
Arizona Hemophilia & Thrombosis Center, located within The University of Arizona Cancer Center

PubMed Identifier	Type	Citation	Retractions
37465396	Derived	Escuriola-Ettingshausen C, Klamroth R, Escobar M, Stasyshyn O, Tangada S, Engl W, Honauer I, Lee HY, Chowdary P, Windyga J. Targeting an elevated FVIII level using personalized rurioctocog alfa pegol prophylaxis in specific patient populations with hemophilia A: post hoc subanalysis of the randomized, phase 3 PROPEL study. Ther Adv Hematol. 2023 Jul 15;14:20406207231178596. doi: 10.1177/20406207231178596. eCollection 2023.
36655343

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	BAX 855-Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 international units per kilogram (IU/kg) intravenous (IV) infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting factor VIII (FVIII) trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of greater than (>) 80 IU/kg were required or regular FVIII peak levels of 200% were reached.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol: Protocol	Jan 13, 2015	Aug 2, 2019

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With a Total Annualized Bleeding Rate (ABR) of Zero for Second Six Months

Annualized bleeding rate was determined by dividing the number of bleeds by observation period in years.

Full analysis set (FAS) included all participants who were randomized to one of the two prophylactic arms and treated prophylactically for any period of time.

Posted

Number

Percentage of participants

Day 183 to Day 364 (6 months)

ID	Title	Description
OG000	BAX 855-Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of > 80 IU/kg were required or regular FVIII peak levels of 200% were reached.
OG001	BAX 855-High Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 every other day, targeting FVIII trough levels of 8-12%. Depending on participant's individual PK, a different dosing interval was considered to prevent regular high FVIII peak levels.

Units	Counts
Participants	OG00057 OG00158

Title

Denominators

Categories

Title	Measurements
	OG00042.1 OG00162.1

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The proportion of participants with an ABR of 0 during the second 6-month period on BAX 855 prophylaxis, was compared between the 2 prophylaxis arms using a chi-square test with continuity correction at a 2-sided 5% level of significance.	Chi-squared		0.0545		Gaussian Statistic estimate	1.960			2-Sided	95	-0.038	3.958			Approximately Gaussian Statistic is obtained by taking the square root of the Chi-squared test with continuity adjustment.		Superiority

Secondary

Total Annualized Bleeding Rate for Second Six Months

Annualized bleeding rate was determined by dividing the number of bleeds by observation period in years.

FAS included all participants who were randomized to one of the two prophylactic arms and treated prophylactically for any period of time. Here "Number of participants analyzed" refer to number of participants evaluable for this outcome at specified time point.

Posted

Mean

Standard Deviation

Bleeds per year

Day 183 to Day 364 (6 months)

ID	Title	Description
OG000	BAX 855-Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of > 80 IU/kg were required or regular FVIII peak levels of 200% were reached.
OG001	BAX 855-High Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 every other day, targeting FVIII trough levels of 8-12%. Depending on participant's individual PK, a different dosing interval was considered to prevent regular high FVIII peak levels.

Secondary

Annualized Spontaneous Bleeding Rate for Second Six Months

Annualized spontaneous bleeding rate was determined by dividing the number of spontaneous bleeds by observation period in years. A bleed was defined as spontaneous if it was not related to injury/trauma.

Posted

Mean

Standard Deviation

Bleeds per year

Day 183 to Day 364 (6 months)

ID	Title	Description
OG000	BAX 855 - Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of > 80 IU/kg were required or regular FVIII peak levels of 200% were reached.
OG001	BAX 855 - High Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 every other day, targeting FVIII trough levels of 8-12%. Depending on participant's individual PK, a different dosing interval was considered to prevent regular high FVIII peak levels.

Secondary

Annualized Traumatic Bleeding Rate for Second Six Months

Annualized traumatic bleeding rate was determined by dividing the number of traumatic bleeds by observation period in years. A bleed was defined as traumatic if it was related to injury/trauma.

Posted

Mean

Standard Deviation

Bleeds per year

Day 183 to Day 364 (6 months)

ID	Title	Description
OG000	BAX 855-Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of > 80 IU/kg were required or regular FVIII peak levels of 200% were reached.
OG001	BAX 855-High Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 every other day, targeting FVIII trough levels of 8-12%. Depending on participant's individual PK, a different dosing interval was considered to prevent regular high FVIII peak levels.

Secondary

Annualized Joint Bleeding Rate (AJBR) for Second Six Months

Annualized joint bleeding rate was determined by dividing the number of joint bleeds by observation period in years. An acute joint bleed include some or all of the following: 'aura', pain, swelling, warmth of the skin over the joint, decreased range of motion and difficulty in using the limb compared with baseline or loss of function.

Posted

Mean

Standard Deviation

Bleeds per year

Day 183 to Day 364 (6 months)

ID	Title	Description
OG000	BAX 855-Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of > 80 IU/kg were required or regular FVIII peak levels of 200% were reached.
OG001	BAX 855-High Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 every other day, targeting FVIII trough levels of 8-12%. Depending on participant's individual PK, a different dosing interval was considered to prevent regular high FVIII peak levels.

Secondary

Total Weight-adjusted Consumption of BAX 855

Total weight-adjusted consumption of BAX 855 were reported.

FAS included all participants who were randomized to one of the two prophylactic arms and treated prophylactically for any period of time.

Posted

Mean

Standard Deviation

International units per kilogram (IU/kg)

From start of study treatment up to 12 months (completion or termination)

ID	Title	Description
OG000	BAX 855-Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of > 80 IU/kg were required or regular FVIII peak levels of 200% were reached.
OG001	BAX 855-High Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 every other day, targeting FVIII trough levels of 8-12%. Depending on participant's individual PK, a different dosing interval was considered to prevent regular high FVIII peak levels.

Secondary

Number of Bleeding Episodes: Overall Hemostatic Efficacy Rating at Number of Infusions

Posted

Number

Treated Bleeds

8 hours after study drug administration

Bleeds

ID	Title	Description
OG000	BAX 855-Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of > 80 IU/kg were required or regular FVIII peak levels of 200% were reached.
OG001

Secondary

Number of Bleeding Episodes: Overall Hemostatic Efficacy Rating at Bleed Resolution

Posted

Number

Treated Bleeds

From start of study treatment up to bleed resolution (up to 12 months)

Bleeds

ID	Title	Description
OG000	BAX 855-Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of > 80 IU/kg were required or regular FVIII peak levels of 200% were reached.

Secondary

Treatment of Bleeding Episodes: Number of BAX 855 Infusions Per Bleeding Episode Required Until Bleed Resolution

Infusions of BAX 855 that were required until bleed resolution were reported.

Posted

Mean

Standard Deviation

Infusions

From start of study treatment up to 12 months (completion or termination)

ID	Title	Description
OG000	BAX 855-Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of > 80 IU/kg were required or regular FVIII peak levels of 200% were reached.
OG001	BAX 855-High Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 every other day, targeting FVIII trough levels of 8-12%. Depending on participant's individual PK, a different dosing interval was considered to prevent regular high FVIII peak levels.

Secondary

Change From Baseline in Hemophilia Joint Health Score (HJHS)- Total Score

HJHS was assessed based on the following components of the elbow, knee, and ankle joints: swelling, duration of swelling, muscle atrophy, crepitus on motion, flexion loss, extension loss, joint pain, and strength, together with an assessment of the global gait. The HJHS is a validated 11-item scoring tool based on radiologic and clinical evaluation, sensitive to detect early signs and minor changes. HJHS ranges from 0 to 124. Higher values in the HJHS represent worse situation for the participant.

Posted

Mean

Standard Deviation

Score on a scale

Baseline, Month 12

ID	Title	Description
OG000	BAX 855-Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of > 80 IU/kg were required or regular FVIII peak levels of 200% were reached.
OG001	BAX 855-High Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 every other day, targeting FVIII trough levels of 8-12%. Depending on participant's individual PK, a different dosing interval was considered to prevent regular high FVIII peak levels.

Secondary

Number of Participants With Hemostatic Efficacy Ratings for BAX 855 Treatment of Operative Bleeds

The participant or caregiver rated the overall treatment response using a 4-point efficacy rating scale as Excellent: Full relief of pain and cessation of objective signs of bleeding after a single infusion and no additional infusion is required for the control of bleeding; Good: Definite pain relief and/or improvement in signs of bleeding after a single infusion and possibly requires more than 1 infusion for complete resolution; Fair: Probable and/or slight relief of pain and slight improvement in signs of bleeding after a single infusion and required more than 1 infusion for complete resolution and None: No improvement or condition worsens. Hemostatic efficacy was evaluated intra-operatively (from start to end of the procedure), post-operatively (from the end of procedure up to 24 h post procedure), and perioperatively (from the start of procedure to participant discharge from hospital or 14 days after completion of procedure; whichever was first).

Surgery analysis set included all participants in the FAS (randomized to one of the two prophylactic arms and treated prophylactically for any period of time) who underwent some form of surgery (including dental) during the course of study participation.

Posted

Count of Participants

Participants

Day 0 through discharge or 14 days post-surgery

ID	Title	Description
OG000	BAX 855-Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of > 80 IU/kg were required or regular FVIII peak levels of 200% were reached.

Secondary

Blood Loss Per Participant in Case of Surgery

The intraoperative blood loss was measured by determining the volume of blood and fluid removal through suction into the collection container (waste box and/or cell saver) and the estimated blood loss into swabs and towels during the procedure, per the anesthesiologist's record. Postoperatively, blood loss was determined by the drainage volume collected, which mainly consisted of drainage fluid via vacuum or gravity drain, as applicable. In cases where no drain was present, blood loss was determined by the surgeon's clinical judgment, as applicable or entered as "not available". Blood loss was evaluated intra-operatively (from start to end of the procedure), post-operatively (from the end of procedure up to 24 h post procedure), and perioperatively (from the start of procedure to participant discharge from hospital or 14 days after completion of procedure; whichever was first).

Posted

Mean

Standard Deviation

Milliliters (mL)

Day 0 through discharge or 14 days post-surgery

ID	Title	Description
OG000	BAX 855-Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of > 80 IU/kg were required or regular FVIII peak levels of 200% were reached.

Secondary

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any unfavorable and unintended sign (an abnormal laboratory finding), symptom (rash, pain, discomfort, fever, dizziness, etc.), disease (peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an investigational product (IP), whether or not considered causally related to the IP. A SAE was defined as an untoward medical occurrence that at any dose met one or more of the following criteria: outcome was fatal/results in death, life-threatening, required in-patient hospitalization or resulted in prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event that was not immediately life-threatening or resulted in death or required hospitalization but jeopardize the participant or required medical or surgical intervention to prevent any of the above outcomes.

SAS included all participants enrolled who had at least one BAX 855 infusion.

Posted

Count of Participants

Participants

From start of study treatment up to 12 months (completion or termination)

ID	Title	Description
OG000	BAX 855-Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 international units per kilogram (IU/kg) intravenous (IV) infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of >80 IU/kg were required or regular FVIII peak levels of 200% were reached.

Secondary

Number of Participants With Clinically Significant Changes in Vital Signs Reported as Treatment Related Adverse Events

Vital signs included systolic and diastolic blood pressure, pulse rate, respiratory rate, body temperature.

SAS included all participants enrolled who had at least one BAX 855 infusion.

Posted

Count of Participants

Participants

From start of study treatment up to 12 months (completion or termination)

ID	Title	Description
OG000	BAX 855-Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of > 80 IU/kg were required or regular FVIII peak levels of 200% were reached.
OG001	BAX 855-High Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 every other day, targeting FVIII trough levels of 8-12%. Depending on participant's individual PK, a different dosing interval was considered to prevent regular high FVIII peak levels.
OG002

Secondary

Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters Reported as Treatment Related Adverse Events

Clinical laboratory assessments included clinical chemistry, hematology, lipid panel, genetics, T-cell, B-cell and NK cell (TBNK) and viral serology.

SAS included all participants enrolled who had at least one BAX 855 infusion.

Posted

Count of Participants

Participants

From start of study treatment up to 12 months (completion or termination)

ID	Title	Description
OG000	BAX 855-Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of > 80 IU/kg were required or regular FVIII peak levels of 200% were reached.
OG001	BAX 855-High Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 every other day, targeting FVIII trough levels of 8-12%. Depending on participant's individual PK, a different dosing interval was considered to prevent regular high FVIII peak levels.

Secondary

Number of Participants With Positive Inhibitory Antibodies and Binding Antibodies to Factor VIII (FVIII), BAX 855, Polyethylene Glycol (PEG), and Chinese Hamster Ovary (CHO) Protein

Positive Inhibitory Antibodies and Binding Antibodies to Factor VIII (FVIII), BAX 855, Polyethylene Glycol (PEG), and Chinese Hamster Ovary (CHO) Protein were reported here.

SAS included all participants enrolled who had at least one BAX 855 infusion.

Posted

Count of Participants

Participants

From start of study treatment up to 12 months (completion or termination)

ID	Title	Description
OG000	BAX 855-Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 international units per kilogram (IU/kg) intravenous (IV) infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of >80 IU/kg were required or regular FVIII peak levels of 200% were reached.
OG001	BAX 855-High Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 every other day, targeting FVIII trough levels of 8-12%. Depending on participant's individual PK, a different dosing interval was considered to prevent regular high FVIII peak levels.

Secondary

Change From Baseline in Physical Component Scores (PCS) of the Short Form-36 (SF-36) Health Survey

Short Form (36) Health Survey (SF-36) is a 36-item validated, generic health related quality of life (HR QoL) instrument. PCS is a summary scale of the dimensions physical functioning, role physical, bodily pain, and general health. The component score is normalized to a standard population. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both sub-scores and summary scores.

Posted

Mean

Standard Deviation

Score on a scale

Baseline, Month 12 (completion or termination)

ID	Title	Description
OG000	BAX 855-Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 international units per kilogram (IU/kg) intravenous (IV) infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of >80 IU/kg were required or regular FVIII peak levels of 200% were reached.
OG001	BAX 855-High Level

Secondary

Area Under the Plasma Concentration of BAX 855 From Zero to Infinity (AUC0-inf)

Area under the plasma concentration versus time curve from time 0 to infinity of BAX 855 were reported.

Pharmacokinetic analysis set (PKAS) included all participants in the SAS that had at least one quantifiable post-dose FVIII activity level without major protocol deviations or events with potential to affect the PK analysis. Here "Number of participants analyzed" refer to number of participants evaluable for this outcome at specified time points.

Posted

Mean

Standard Deviation

International units*hour per deciliter

Pre-infusion, 15 - 30 minutes, 3, 8, 24, 48, 72 and 96 hours post-infusion

ID	Title	Description
OG000	BAX 855-Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 international units per kilogram (IU/kg) intravenous (IV) infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of >80 IU/kg were required or regular FVIII peak levels of 200% were reached.
OG001	BAX 855-High Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 every other day, targeting FVIII trough levels of 8-12%. Depending on participant's individual PK, a different dosing interval was considered to prevent regular high FVIII peak levels.

Secondary

Incremental Recovery (IR) at Maximum Plasma Concentration (Cmax) of BAX 855

IR at Cmax of BAX 855 were reported.

PKAS included all participants in the SAS that had at least one quantifiable post-dose FVIII activity level without major protocol deviations or events with potential to affect the PK analysis. Here "Number of participants analyzed" refer to number of participants evaluable for this outcome at specified time points.

Posted

Mean

Standard Deviation

(IU/dL) / (IU/kg)

Pre-infusion, 15 - 30 minutes, 3, 8, 24, 48, 72 and 96 hours post-infusion

ID	Title	Description
OG000	BAX 855-Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 international units per kilogram (IU/kg) intravenous (IV) infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of >80 IU/kg were required or regular FVIII peak levels of 200% were reached.
OG001	BAX 855-High Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 every other day, targeting FVIII trough levels of 8-12%. Depending on participant's individual PK, a different dosing interval was considered to prevent regular high FVIII peak levels.

Secondary

Plasma Half-life (T1/2) of BAX 855

T1/2 of BAX 855 in plasma were reported.

PKAS included all participants in the SAS that had at least one quantifiable post-dose FVIII activity level without major protocol deviations or events with potential to affect the PK analysis.

Posted

Median

Full Range

hour (h)

Pre-infusion, 15 - 30 minutes, 3, 8, 24, 48, 72 and 96 hours post-infusion

ID	Title	Description
OG000	BAX 855-Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 international units per kilogram (IU/kg) intravenous (IV) infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of >80 IU/kg were required or regular FVIII peak levels of 200% were reached.
OG001	BAX 855-High Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 every other day, targeting FVIII trough levels of 8-12%. Depending on participant's individual PK, a different dosing interval was considered to prevent regular high FVIII peak levels.
OG002

Secondary

Mean Residence Time (MRT) of BAX 855

MRT of BAX 855 were reported.

Pharmacokinetic analysis set (PKAS) included all participants in the SAS (participants enrolled who had at least 1 BAX 855 infusion) that had at least one quantifiable post-dose FVIII activity level without major protocol deviations or events with potential to affect the PK analysis.

Posted

Median

Full Range

hour (h)

Pre-infusion, 15 - 30 minutes, 3, 8, 24, 48, 72 and 96 hours post-infusion

ID	Title	Description
OG000	BAX 855-Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 international units per kilogram (IU/kg) intravenous (IV) infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of >80 IU/kg were required or regular FVIII peak levels of 200% were reached.
OG001	BAX 855-High Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 every other day, targeting FVIII trough levels of 8-12%. Depending on participant's individual PK, a different dosing interval was considered to prevent regular high FVIII peak levels.

Secondary

Maximum Plasma Concentration (Cmax) of BAX 855

Cmax of BAX 855 were reported.

Posted

Mean

Standard Deviation

International units per deciliter(IU/dL)

Pre-infusion, 15 - 30 minutes, 3, 8, 24, 48, 72 and 96 hours post-infusion

ID	Title	Description
OG000	BAX 855-Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 international units per kilogram (IU/kg) intravenous (IV) infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of >80 IU/kg were required or regular FVIII peak levels of 200% were reached.
OG001	BAX 855-High Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 every other day, targeting FVIII trough levels of 8-12%. Depending on participant's individual PK, a different dosing interval was considered to prevent regular high FVIII peak levels.

Secondary

Time to Maximum Concentration of BAX 855 in Plasma (Tmax)

Tmax of BAX 855 were reported.

PKAS included all participants in the SAS that had at least one quantifiable post-dose FVIII activity level without major protocol deviations or events with potential to affect the PK analysis.

Posted

Median

Full Range

hour (h)

Pre-infusion, 15 - 30 minutes, 3, 8, 24, 48, 72 and 96 hours post-infusion

ID	Title	Description
OG000	BAX 855-Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 international units per kilogram (IU/kg) intravenous (IV) infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of >80 IU/kg were required or regular FVIII peak levels of 200% were reached.
OG001	BAX 855-High Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 every other day, targeting FVIII trough levels of 8-12%. Depending on participant's individual PK, a different dosing interval was considered to prevent regular high FVIII peak levels.
OG002

Secondary

Total Body Clearance (CL) of BAX 855

Total body clearance of BAX 855 from blood by the kidney were reported.

PKAS included all participants in the SAS that had at least one quantifiable post-dose FVIII activity level without major protocol deviations or events with potential to affect the PK analysis.

Posted

Mean

Standard Deviation

Deciliters per kilogram * hour (dL/kg*h)

Pre-infusion, 15 - 30 minutes, 3, 8, 24, 48, 72 and 96 hours post-infusion

ID	Title	Description
OG000	BAX 855-Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 international units per kilogram (IU/kg) intravenous (IV) infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of >80 IU/kg were required or regular FVIII peak levels of 200% were reached.
OG001	BAX 855-High Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 every other day, targeting FVIII trough levels of 8-12%. Depending on participant's individual PK, a different dosing interval was considered to prevent regular high FVIII peak levels.

Secondary

Volume of Distribution at Steady State (Vss)

Volume of distribution was defined as the theoretical volume in which the total amount of drug was uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steadystate.

PKAS included all participants in the SAS that had at least one quantifiable post-dose FVIII activity level without major protocol deviations or events with potential to affect the PK analysis.

Posted

Mean

Standard Deviation

Deciliters per kilogram (dL/kg)

Pre-infusion, 15 - 30 minutes, 3, 8, 24, 48, 72 and 96 hours post-infusion

ID	Title	Description
OG000	BAX 855-Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 international units per kilogram (IU/kg) intravenous (IV) infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of >80 IU/kg were required or regular FVIII peak levels of 200% were reached.
OG001	BAX 855-High Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 every other day, targeting FVIII trough levels of 8-12%. Depending on participant's individual PK, a different dosing interval was considered to prevent regular high FVIII peak levels.

Secondary

Incremental Recovery (IR) Over Time

Incremental recovery was calculated by BAX 855 increment (IU/dL) / BAX 855 dose (IU/kg).

Posted

Mean

Standard Deviation

IU/dL per IU/kg

Baseline, Month 3, 6, 7.5, 9, 10.5, 12 (Completion or termination)

ID	Title	Description
OG000	BAX 855-Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of > 80 IU/kg were required or regular FVIII peak levels of 200% were reached.
OG001	BAX 855-High Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 every other day, targeting FVIII trough levels of 8-12%. Depending on participant's individual PK, a different dosing interval was considered to prevent regular high FVIII peak levels.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Factor viii inhibition	Blood and lymphatic system disorders	MedDRA 21.0	Non-systematic Assessment	EG0000 events0 affected57 at risk EG0011 events1 affected58 at risk EG0020 events0 affected6 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Non-systematic Assessment	EG0001 events1 affected57 at risk EG0010 events0 affected58 at risk EG0020 events0 affected6 at risk
Abscess limb	Infections and infestations	MedDRA 21.0	Non-systematic Assessment	EG0001 events1 affected57 at risk EG0010 events0 affected58 at risk EG0020 events0 affected6 at risk
Appendicitis	Infections and infestations	MedDRA 21.0	Non-systematic Assessment	EG0001 events1 affected57 at risk EG0010 events0 affected58 at risk EG0020 events0 affected6 at risk
Cellulitis	Infections and infestations	MedDRA 21.0	Non-systematic Assessment	EG0001 events1 affected57 at risk EG0010 events0 affected58 at risk EG0020 events0 affected6 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Non-systematic Assessment	EG0000 events0 affected57 at risk EG0011 events1 affected58 at risk EG0020 events0 affected6 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 21.0	Non-systematic Assessment	EG0001 events1 affected57 at risk EG0011 events1 affected58 at risk EG0020 events0 affected6 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 21.0	Non-systematic Assessment	EG0000 events0 affected57 at risk EG0011 events1 affected58 at risk EG0020 events0 affected6 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 21.0	Non-systematic Assessment	EG0000 events0 affected57 at risk EG0011 events1 affected58 at risk EG0020 events0 affected6 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Non-systematic Assessment	EG0001 events1 affected57 at risk EG0010 events0 affected58 at risk EG0020 events0 affected6 at risk
Cerebellar haematoma	Nervous system disorders	MedDRA 21.0	Non-systematic Assessment	EG0000 events0 affected57 at risk EG0011 events1 affected58 at risk EG0020 events0 affected6 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Non-systematic Assessment	EG0007 events6 affected57 at risk EG0015 events5 affected58 at risk EG0020 events0 affected6 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Non-systematic Assessment	EG0002 events1 affected57 at risk EG0013 events3 affected58 at risk EG0020 events0 affected6 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Non-systematic Assessment	EG0003 events3 affected57 at risk EG0012 events2 affected58 at risk EG0020 events0 affected6 at risk
Pyrexia	General disorders	MedDRA 21.0	Non-systematic Assessment	EG0002 events2 affected57 at risk EG0013 events3 affected58 at risk EG0020 events0 affected6 at risk
Nasopharyngitis	Infections and infestations	MedDRA 21.0	Non-systematic Assessment	EG0008 events6 affected57 at risk EG0016 events5 affected58 at risk EG0020 events0 affected6 at risk
Rhinitis	Infections and infestations	MedDRA 21.0	Non-systematic Assessment	EG0003 events3 affected57 at risk EG0013 events3 affected58 at risk EG0020 events0 affected6 at risk
Sinusitis	Infections and infestations	MedDRA 21.0	Non-systematic Assessment	EG0003 events3 affected57 at risk EG0010 events0 affected58 at risk EG0020 events0 affected6 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Non-systematic Assessment	EG00011 events6 affected57 at risk EG00116 events12 affected58 at risk EG0020 events0 affected6 at risk
Headache	Nervous system disorders	MedDRA 21.0	Non-systematic Assessment	EG0007 events5 affected57 at risk EG0017 events6 affected58 at risk EG0020 events0 affected6 at risk

ID	Term
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D020147	Coagulation Protein Disorders
D006474	Hemorrhagic Disorders
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

ID	Title	Description
BG000	BAX 855-Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of > 80 IU/kg were required or regular FVIII peak levels of 200% were reached.
BG001	BAX 855-High Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 every other day, targeting FVIII trough levels of 8-12%. Depending on participant's individual PK, a different dosing interval was considered to prevent regular high FVIII peak levels.
BG002	BAX 855-Non-randomized	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) and were not randomized to any treatments.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	BAX 855-Low Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 twice weekly (Alternating 3 and 4-day infusion intervals or an infusion every 3.5 days), targeting FVIII trough levels of 1-3%. Depending on participant's individual PK, more frequent dosing was considered if single doses of > 80 IU/kg were required or regular FVIII peak levels of 200% were reached.	57	5	57	25	57
EG001	BAX 855-High Level	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) followed by a PK-guided dose of BAX 855 every other day, targeting FVIII trough levels of 8-12%. Depending on participant's individual PK, a different dosing interval was considered to prevent regular high FVIII peak levels.	58	5	58	25	58
EG002	BAX 855-Non-randomized	Participants with severe hemophilia A received a single BAX 855 dose of 60 +/- 5 IU/kg IV infusion (PK assessment) and were not randomized to any treatments.	6	0	6	0	6