NCT01945593 is a Phase 3 clinical trial of BAX855 in Hemophilia A, sponsored by Baxalta now part of Shire.

Who is sponsoring NCT01945593?

NCT01945593 is sponsored by Baxalta now part of Shire.

What drugs are being tested in NCT01945593?

Interventions in NCT01945593: BAX855.

What condition does NCT01945593 study?

NCT01945593 studies Hemophilia A.

Is NCT01945593 still recruiting?

NCT01945593 is currently completed. Last updated 24 May 2021.

Are results published for NCT01945593?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-05-24 · How we verify

NCT01945593

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

BAX 855 Continuation

Completed Phase 3 Results posted Last updated 24 May 2021

What this trial tests

Phase 3 trial testing BAX855 in Hemophilia A in 218 participants. Completed in 2 March 2018.

Timeline

15 October 2013

Primary endpoint
2 March 2018

2 March 2018

Quick facts

Lead sponsor	Baxalta now part of Shire
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	218
Start date	15 October 2013
Primary completion	2 March 2018
Estimated completion	2 March 2018
Sites	89 locations across Hong Kong, Japan, Malaysia, Taiwan, Poland, South Korea, Netherlands, Russia

Drugs / interventions tested

BAX855 — full drug profile →

Conditions studied

Hemophilia A — all drugs for Hemophilia A →

Sponsor

Baxalta now part of Shire — full company profile →

Who can join

Under 75, any sex, with Hemophilia A. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Inhibitory Antibodies to Factor VIII (FVIII) Primary · Baseline through end of study (53 months)

Inhibitory antibodies to Factor VIII were measured by the Nijmegen modification of the Bethesda assay. Inhibitors had to be confirmed by 2 separate assessments within a 2 to 4 week period from the central laboratory.

Group	Value	95% CI
BAX 855: Age < 2 Years	0
BAX 855: Age >= 2 to <12 Years	0
BAX 855: Age >= 12 to <17 Years	0
BAX 855: Age >= 17 Years	0

Annualized Bleed Rate (ABR) - Spontaneous Bleeds Primary · Baseline through end of study (53 months)

The ABR was assessed based upon each individual bleeding episode. A bleeding episode was defined as subjective (pain consistent with a joint bleed) or objective evidence of bleeding which may or may not require treatment with FVIII. The ABR of spontaneous bleeds was reported separately for twice weekly, PK-t R, each of the every 5 days and every 7 days treatment regimens at the time of bleed.

Fixed-dose regimen (FDR): Every 5 Days

Group	Value	95% CI
BAX 855: Age >= 12 to <17 Years	1.381	0.728 – 2.620
BAX 855: Age >= 17 Years	1.160	0.727 – 1.852

FDR: Every 7 Days

Group	Value	95% CI
BAX 855: Age >= 12 to <17 Years	0.669	0.061 – 7.377
BAX 855: Age >= 17 Years	1.992	0.822 – 4.827

FDR: Twice Weekly

Group	Value	95% CI
BAX 855: Age < 2 Years	0.614	0.154 – 2.454
BAX 855: Age >= 2 to <12 Years	0.792	0.518 – 1.210
BAX 855: Age >= 12 to <17 Years	1.439	0.942 – 2.200
BAX 855: Age >= 17 Years	1.293	0.913 – 1.832

PK-tailored regimen (PK-t R)

Group	Value	95% CI
BAX 855: Age >= 2 to <12 Years	1.078	0.450 – 2.581
BAX 855: Age >= 12 to <17 Years	1.602	0.270 – 9.486
BAX 855: Age >= 17 Years	0.868	0.365 – 2.067

Total Annualized Bleed Rate (ABR) Secondary · Baseline through end of study (53 months)

The ABR was assessed based upon each individual bleeding episode. A bleeding episode was defined as subjective (pain consistent with a joint bleed) or objective evidence of bleeding which may or may not require treatment with FVIII. Bleeding occurring at multiple locations related to the same injury (e.g., knee and ankle bleed following a fall) was counted as a single bleeding episode. Total annualized bleed rate (spontaneous and traumatic bleeding episodes) was reported.

Group	Value	95% CI
BAX 855: Age < 2 Years	1.855	± 1.000
BAX 855: Age >= 2 to <12 Years	2.370	± 3.027
BAX 855: Age >= 12 to <17 Years	3.175	± 2.797
BAX 855: Age >= 17 Years	2.426	± 3.258

Overall Hemostatic Efficacy Rating of BAX 855 for Treatment of Breakthrough Bleeding Episodes Secondary · Baseline through end of study (53 months)

The participant or caregiver rated the overall treatment response at 24 (+/- 2) hours after the initiation of treatment 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: Slight relief of pain and slight improvement in signs of bleeding after a single infusion and required mor

Excellent

Group	Value	95% CI
BAX 855: Age < 2 Years	3
BAX 855: Age >= 2 to <12 Years	108
BAX 855: Age >= 12 to <17 Years	98
BAX 855: Age >= 17 Years	229

Good

Group	Value	95% CI
BAX 855: Age < 2 Years	3
BAX 855: Age >= 2 to <12 Years	66
BAX 855: Age >= 12 to <17 Years	49
BAX 855: Age >= 17 Years	250

Fair

Group	Value	95% CI
BAX 855: Age < 2 Years	0
BAX 855: Age >= 2 to <12 Years	5
BAX 855: Age >= 12 to <17 Years	7
BAX 855: Age >= 17 Years	36

None

Group	Value	95% CI
BAX 855: Age < 2 Years	0
BAX 855: Age >= 2 to <12 Years	0
BAX 855: Age >= 12 to <17 Years	1
BAX 855: Age >= 17 Years	3

Not Reported

Group	Value	95% CI
BAX 855: Age < 2 Years	0
BAX 855: Age >= 2 to <12 Years	13
BAX 855: Age >= 12 to <17 Years	13
BAX 855: Age >= 17 Years	26

BAX 855 Infusions Needed to Treat Bleeding Episodes Secondary · Baseline through end of study (53 months)

The BAX 855 infusions to treat each bleeding episode was determined by the participant, the participant's caregiver, and/or investigator, and was based upon the participant's response to treatment. A bleeding episode was defined as subjective (pain consistent with a joint bleed) or objective evidence of bleeding which may or may not require treatment with FVIII.

Group	Value	95% CI
BAX 855: Age < 2 Years	1.3	± 0.52
BAX 855: Age >= 2 to <12 Years	1.4	± 1.14
BAX 855: Age >= 12 to <17 Years	1.4	± 1.81
BAX 855: Age >= 17 Years	1.4	± 1.10

Total Time Intervals Between Bleeding Episodes Secondary · Baseline through end of study (53 months)

The time interval between bleeding episodes was calculated based upon the date and time reported for each bleeding episode. A bleeding episode was defined as subjective (pain consistent with a joint bleed) or objective evidence of bleeding which may or may not require treatment with FVIII.

Group	Value	95% CI
BAX 855: Age < 2 Years	5.700	4.074 – 7.327
BAX 855: Age >= 2 to <12 Years	5.051	0.756 – 14.867
BAX 855: Age >= 12 to <17 Years	5.232	1.228 – 14.571
BAX 855: Age >= 17 Years	5.818	0.617 – 22.686

Average Dose of BAX 855 Per Prophylactic Infusion Secondary · Baseline through end of study (53 months)

The average dose of BAX 855 per prophylactic infusion was reported.

Group	Value	95% CI
BAX 855: Age < 2 Years	50.748	± 11.312
BAX 855: Age >= 2 to <12 Years	53.855	± 7.754
BAX 855: Age >= 12 to <17 Years	53.356	± 10.344
BAX 855: Age >= 17 Years	49.727	± 8.677

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Secondary · Baseline through end of study (53 months)

An AE was any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, 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 serious adverse event (SAE) was defined as an untoward medical occurrence that at any dose met one or more of the following criteria: outcome was fatal/resulted in death; was life-threatening; required inpatient hospitalization or resulted in prolongation of an

Group	Value	95% CI
BAX 855: Age < 2 Years	3
BAX 855: Age >= 2 to <12 Years	52
BAX 855: Age >= 12 to <17 Years	18
BAX 855: Age >= 17 Years	101

SAE

Group	Value	95% CI
BAX 855: Age < 2 Years	0
BAX 855: Age >= 2 to <12 Years	7
BAX 855: Age >= 12 to <17 Years	4
BAX 855: Age >= 17 Years	22

Change From Baseline in Body Temperature Secondary · Baseline, end of study (53 months)

Change in body temperature at pre-infusion and post-infusion at end of the study was reported. In the below table, FDR refers to fixed dose regimen, PK-tR refers to PK tailored regimen at the time of sampling.

FDR: Pre-Infusion

Group	Value	95% CI
BAX 855: Age < 2 Years	-0.23	± 0.208
BAX 855: Age >= 2 to <12 Years	-0.05	± 0.386
BAX 855: Age >= 12 to <17 Years	-0.08	± 0.409
BAX 855: Age >= 17 Years	-0.01	± 0.376

FDR: Post-Infusion

Group	Value	95% CI
BAX 855: Age < 2 Years	-0.07	± 0.306
BAX 855: Age >= 2 to <12 Years	-0.03	± 0.394
BAX 855: Age >= 12 to <17 Years	0.03	± 0.375
BAX 855: Age >= 17 Years	-0.02	± 0.395

PK-tR: Pre-Infusion

Group	Value	95% CI
BAX 855: Age >= 2 to <12 Years	0.28	± 0.255
BAX 855: Age >= 12 to <17 Years	-0.08	± 0.189
BAX 855: Age >= 17 Years	-0.10	± 0.595

PK-tR: Post-Infusion

Group	Value	95% CI
BAX 855: Age >= 2 to <12 Years	0.13	± 0.362
BAX 855: Age >= 12 to <17 Years	0.03	± 0.263
BAX 855: Age >= 17 Years	0.01	± 0.593

Change From Baseline in Pulse Rate Secondary · Baseline, end of study (53 months)

Change in pulse rate at pre-infusion and post-infusion at end of the study was reported. In the below table, FDR refers to fixed dose regimen, PK-tR refers to PK tailored regimen at the time of sampling.

FDR: Pre-Infusion

Group	Value	95% CI
BAX 855: Age < 2 Years	-20.3	± 21.22
BAX 855: Age >= 2 to <12 Years	-0.1	± 14.31
BAX 855: Age >= 12 to <17 Years	-7.7	± 9.07
BAX 855: Age >= 17 Years	-0.4	± 11.67

FDR: Post-Infusion

Group	Value	95% CI
BAX 855: Age < 2 Years	-13	± 19.47
BAX 855: Age >= 2 to <12 Years	2.4	± 16.72
BAX 855: Age >= 12 to <17 Years	-6.2	± 8.55
BAX 855: Age >= 17 Years	-1	± 10.07

PK-tR: Pre-Infusion

Group	Value	95% CI
BAX 855: Age >= 2 to <12 Years	0.1	± 9.13
BAX 855: Age >= 12 to <17 Years	-1.8	± 13.91
BAX 855: Age >= 17 Years	4.0	± 9.15

PK-tR: Post-Infusion

Group	Value	95% CI
BAX 855: Age >= 2 to <12 Years	-8.1	± 14.94
BAX 855: Age >= 12 to <17 Years	-4.5	± 12.40
BAX 855: Age >= 17 Years	-0.2	± 7.31

Change From Baseline in Respiratory Rate Secondary · Baseline, end of study (53 months)

Change in respiratory rate at pre-infusion and post-infusion at end of the study was reported. In the below table, FDR refers to fixed dose regimen, PK-tR refers to PK tailored regimen at the time of sampling.

FDR: Pre-Infusion

Group	Value	95% CI
BAX 855: Age < 2 Years	-6.3	± 4.73
BAX 855: Age >= 2 to <12 Years	-0.8	± 3.97
BAX 855: Age >= 12 to <17 Years	-1.3	± 1.67
BAX 855: Age >= 17 Years	0.4	± 2.85

FDR: Post-Infusion

Group	Value	95% CI
BAX 855: Age < 2 Years	-6.3	± 4.73
BAX 855: Age >= 2 to <12 Years	-1.3	± 3.55
BAX 855: Age >= 12 to <17 Years	-1.5	± 1.85
BAX 855: Age >= 17 Years	0.2	± 2.88

PK-tR: Pre-Infusion

Group	Value	95% CI
BAX 855: Age >= 2 to <12 Years	1.5	± 7.01
BAX 855: Age >= 12 to <17 Years	-3.5	± 5.74
BAX 855: Age >= 17 Years	0.2	± 2.79

PK-tR: Post-Infusion

Group	Value	95% CI
BAX 855: Age >= 2 to <12 Years	0.4	± 5.73
BAX 855: Age >= 12 to <17 Years	-3.3	± 5.85
BAX 855: Age >= 17 Years	0.3	± 2.55

Change From Baseline in Blood Pressure Secondary · Baseline, end of study (53 months)

Change in systolic and diastolic blood pressure at pre-infusion and post-infusion at end of the study were reported. In the below table, FDR refers to fixed dose regimen, PK-tR refers to PK tailored regimen at the time of sampling, SBP refers to systolic blood pressure, DBP refers to diastolic blood pressure.

SBP - FDR: Pre-Infusion

Group	Value	95% CI
BAX 855: Age < 2 Years	-2.7	± 1.53
BAX 855: Age >= 2 to <12 Years	4.5	± 11.82
BAX 855: Age >= 12 to <17 Years	4.0	± 9.25
BAX 855: Age >= 17 Years	1.8	± 12.87

SBP - FDR: Post-Infusion

Group	Value	95% CI
BAX 855: Age < 2 Years	-8.7	± 8.50
BAX 855: Age >= 2 to <12 Years	3	± 11.49
BAX 855: Age >= 12 to <17 Years	2.7	± 8.65
BAX 855: Age >= 17 Years	-1.4	± 12.08

SBP - PK-tR: Pre-Infusion

Group	Value	95% CI
BAX 855: Age >= 2 to <12 Years	0.9	± 8.04
BAX 855: Age >= 12 to <17 Years	3.5	± 9.15
BAX 855: Age >= 17 Years	1.0	± 14.54

SBP - PK-tR: Post-Infusion

Group	Value	95% CI
BAX 855: Age >= 2 to <12 Years	-1.8	± 8.61
BAX 855: Age >= 12 to <17 Years	3.8	± 6.4
BAX 855: Age >= 17 Years	4.9	± 15.14

DBP - FDR: Pre-Infusion

Group	Value	95% CI
BAX 855: Age < 2 Years	0.7	± 8.02
BAX 855: Age >= 2 to <12 Years	1.8	± 9.73
BAX 855: Age >= 12 to <17 Years	1.4	± 9.69
BAX 855: Age >= 17 Years	1.8	± 8.66

DBP - FDR: Post-Infusion

Group	Value	95% CI
BAX 855: Age < 2 Years	5.3	± 8.74
BAX 855: Age >= 2 to <12 Years	3	± 9.72
BAX 855: Age >= 12 to <17 Years	0.3	± 6.43
BAX 855: Age >= 17 Years	0.4	± 9.21

DBP - PK-tR: Pre-Infusion

Group	Value	95% CI
BAX 855: Age >= 2 to <12 Years	2.3	± 9.65
BAX 855: Age >= 12 to <17 Years	0.5	± 10.28
BAX 855: Age >= 17 Years	1.5	± 7.90

DBP - PK-tR: Post-Infusion

Group	Value	95% CI
BAX 855: Age >= 2 to <12 Years	-2.4	± 6.67
BAX 855: Age >= 12 to <17 Years	-2.3	± 7.68
BAX 855: Age >= 17 Years	-0.9	± 7.93

Adverse events — posted to ClinicalTrials.gov

Time frame: From start of study drug administration up to 53 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BAX 855: Age < 2 Years

Serious: 0/3 (0%)

Deaths: 0/3

BAX 855: Age >= 2 to <12 Years

Serious: 7/62 (11%)

Deaths: 0/62

BAX 855: Age >= 12 to <17 Years

Serious: 4/26 (15%)

Deaths: 1/26

BAX 855: Age >= 17 Years

Serious: 22/125 (18%)

Deaths: 0/125

Serious adverse events (43 terms)

Reaction	System	BAX 855: Age < 2 Years	BAX 855: Age >= 2 to <12 Y…	BAX 855: Age >= 12 to <17 …	BAX 855: Age >= 17 Years
Haemarthrosis	Musculoskeletal and connective tissue disorders	—	—	—	—
Haematoma	Vascular disorders	—	—	—	—
Pancreatitis	Gastrointestinal disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Splenic haematoma	Blood and lymphatic system disorders	—	—	—	—
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	—	—	—	—
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Renal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Ileus	Gastrointestinal disorders	—	—	—	—
Abscess oral	Infections and infestations	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—
Bacteraemia	Infections and infestations	—	—	—	—
Cystitis	Infections and infestations	—	—	—	—
Device related infection	Infections and infestations	—	—	—	—
Device related sepsis	Infections and infestations	—	—	—	—
Incision site abscess	Infections and infestations	—	—	—	—
Laryngitis	Infections and infestations	—	—	—	—
Plasmodium falciparum infection	Infections and infestations	—	—	—	—
Skin infection	Infections and infestations	—	—	—	—
Streptococcal bacteraemia	Infections and infestations	—	—	—	—
Tonsillitis	Infections and infestations	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—

Other adverse events (24 terms — click to expand)

Reaction	System	BAX 855: Age < 2 Years	BAX 855: Age >= 2 to <12 Y…	BAX 855: Age >= 12 to <17 …	BAX 855: Age >= 17 Years
Nasopharyngitis	Infections and infestations	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Influenza	Infections and infestations	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—
Ear infection	Infections and infestations	—	—	—	—
Pharyngitis streptococcal	Infections and infestations	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—
Ligament sprain	Injury, poisoning and procedural complications	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Limb injury	Injury, poisoning and procedural complications	—	—	—	—
Iron deficiency anaemia	Blood and lymphatic system disorders	—	—	—	—
Enterovirus infection	Infections and infestations	—	—	—	—
Otitis media acute	Infections and infestations	—	—	—	—
Skull fracture	Injury, poisoning and procedural complications	—	—	—	—
Febrile convulsion	Nervous system disorders	—	—	—	—
Pharyngeal ulceration	Respiratory, thoracic and mediastinal disorders	—	—	—	—

Most-reported serious reactions: Haemarthrosis, Haematoma, Pancreatitis, Pyrexia, Pneumonia, Urinary tract infection, Anaemia, Splenic haematoma.

Data from ClinicalTrials.gov NCT01945593 adverse events section.

Sponsor's own description

To continue the evaluation of the safety and efficacy of BAX 855 for prophylaxis and treatment of bleeding episodes in adult and pediatric previously treated patients (PTPs) aged ≤ 75 years of age with severe hemophilia A.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Rurioctocog alfa pegol PK-guided prophylaxis in hemophilia A: results from the phase 3 PROPEL study.
Klamroth R, Windyga J, Radulescu V, Collins PW, et al · · 2021 · cited 61× · PMID 33150384 · DOI 10.1182/blood.2020005673
Long-term safety and efficacy results from the phase 3b, open-label, multicentre Continuation study of rurioctocog alfa pegol for prophylaxis in previously treated patients with severe haemophilia A.
Chowdary P, Mullins ES, Konkle BA, McGuinn C, et al · · 2020 · cited 23× · PMID 32597029 · DOI 10.1111/hae.14052
Efficacy, safety, and immunogenicity of rurioctocog alfa pegol for prophylactic treatment in previously treated patients with severe hemophilia A: a systematic review and meta-analysis of clinical trials.
Witarto BS, Visuddho V, Witarto AP, Sutanto H, et al · · 2021 · cited 5× · PMID 35136579 · DOI 10.12688/f1000research.73884.3
Abstracts
· 2020
Abstracts
· 2019

Verify or expand the search:

Other recruiting trials for Hemophilia A

Currently open trials in the same condition.

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Other Baxalta now part of Shire trials

Trials by the same sponsor.

NCT04985682 — A Study of ADVATE in People With Hemophilia A in India · Phase 4 · completed
NCT04578535 — A Study to Assess the Tolerability, Safety, and Pharmacokinetics of Subcutaneous Immune Globulin Infusion 10% (Human) Wi · Phase 1 · completed
NCT04346108 — A Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunode · Phase 3 · completed
NCT04158934 — A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A · active not recruiting
NCT04394286 — A Phase 1/2 Study of SHP648, an Adeno-Associated Viral Vector for Gene Transfer in Hemophilia B Subjects · Phase 1, PHASE2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01945593 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Baxalta now part of Shire
Last refreshed: 24 May 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01945593.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01945593

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (43 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Hemophilia A

Other Baxalta now part of Shire trials

Verify against primary sources