Who is sponsoring NCT02283268?

NCT02283268 is sponsored by Baxalta now part of Shire.

What drugs are being tested in NCT02283268?

Interventions in NCT02283268: Recombinant von Willebrand Factor (rVWF).

What condition does NCT02283268 study?

NCT02283268 studies Von Willebrand Disease.

Is NCT02283268 still recruiting?

NCT02283268 is currently completed. Last updated 19 May 2021.

Are results published for NCT02283268?

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

Last reviewed 2021-05-19 · How we verify

NCT02283268

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

Recombinant Von Willebrand Factor in Subjects With Severe Von Willebrand Disease Undergoing Surgery

Completed Phase 3 Results posted Last updated 19 May 2021

What this trial tests

Phase 3 trial testing Recombinant von Willebrand Factor (rVWF) in Von Willebrand Disease in 24 participants. Completed in 6 July 2016.

Timeline

1 April 2015

Primary endpoint
6 July 2016

6 July 2016

Quick facts

Lead sponsor	Baxalta now part of Shire
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	1 April 2015
Primary completion	6 July 2016
Estimated completion	6 July 2016
Sites	34 locations across Italy, Netherlands, Russia, Ukraine, Austria, Taiwan, United Kingdom, Germany

Drugs / interventions tested

Recombinant von Willebrand Factor (rVWF) — full drug profile →

Conditions studied

Von Willebrand Disease — all drugs for Von Willebrand Disease →

Sponsor

Baxalta now part of Shire — full company profile →

Who can join

18 and older, any sex, with Von Willebrand Disease. 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.

Overall Hemostatic Efficacy as Assessed by the Investigator (Hemophilia Physician) Primary · 24 hours after last peri-operative infusion or at completion of Day 14 (± 2 days) visit, whichever occurs earlier

Hemostatic efficacy will be rated on a scale of excellent - good - moderate - none. Excellent: Intra-, and postoperative hemostasis achieved with rVWF with our without ADVATE was as good or better than that expected for the type of surgical procedure performed in a hemostatically normal subject. Good: Intra-, and postoperative hemostasis achieved with rVWF with or without ADVATE was probably as good as that expected for the type of surgical procedure performed in a hemostatically normal subject. Moderate: Intra-, and postoperative hemostasis with rVWF with or without ADVATE was clearly less th

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	11
Minor Surgery	4
Major Surgery	7
Oral Surgery	0
Von Willebrand Disease Type 1	2
Von Willebrand Disease Type 2A	1
Von Willebrand Disease Type 2B	1
Von Willebrand Disease Type 2M	0
Von Willebrand Disease Type 3	7
Recombinant Von Willebrand Factor (rVWF)	4
Minor Surgery	0
Major Surgery	3
Oral Surgery	1
Von Willebrand Disease Type 1	1
Von Willebrand Disease Type 2A	1
Von Willebrand Disease Type 2B	0
Von Willebrand Disease Type 2M	1
Von Willebrand Disease Type 3	1
Recombinant Von Willebrand Factor (rVWF)	0
Minor Surgery	0
Major Surgery	0
Oral Surgery	0
Von Willebrand Disease Type 1	0
Von Willebrand Disease Type 2A	0
Von Willebrand Disease Type 2B	0
Von Willebrand Disease Type 2M	0
Von Willebrand Disease Type 3	0
Recombinant Von Willebrand Factor (rVWF)	0
Minor Surgery	0
Major Surgery	0
Oral Surgery	0
Von Willebrand Disease Type 1	0
Von Willebrand Disease Type 2A	0
Von Willebrand Disease Type 2B	0
Von Willebrand Disease Type 2M	0
Von Willebrand Disease Type 3	0

Intraoperative Actual Versus Predicted Blood Loss as Assessed by the Operating Surgeon Secondary · Day 0 (at completion of surgery)

The predicted blood loss will be estimated preoperatively by the operating surgeon based on a hemostatically normal individual of the same sex, age, stature and co-morbidities as the participant. The actual blood loss will be assessed consisting of the estimated blood loss, including into swabs, towels and suction during the procedure, per the anesthesiologist's record.

Actual blood loss

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	94.3	± 177.88
Minor Surgery	0.0	± 0.00
Major Surgery	127.0	± 209.27
Oral Surgery	145.0	± NA
Von Willebrand Disease Type 1	115.0	± 103.32
Von Willebrand Disease Type 2A	42.5	± 53.03
Von Willebrand Disease Type 2B	50.0	± NA
Von Willebrand Disease Type 2M	50.0	± NA
Von Willebrand Disease Type 3	110.6	± 240.87

Predicted blood loss

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	106.1	± 161.82
Minor Surgery	2.5	± 5.00
Major Surgery	152.8	± 186.33
Oral Surgery	100.0	± NA
Von Willebrand Disease Type 1	100.0	± 100.00
Von Willebrand Disease Type 2A	10.0	± NA
Von Willebrand Disease Type 2B	50.0	± NA
Von Willebrand Disease Type 2M	50.0	± NA
Von Willebrand Disease Type 3	134.4	± 206.46

Intraoperative Actual Blood Loss Relative to Predicted Blood Loss Secondary · Day 0 (at completion of surgery)

Actual blood loss relative to predicted blood loss will be calculated as \[Actual Blood loss (mL)\] divided by \[Predicted Blood Loss (mL) multiplied by 100.

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	69.6	± 44.77
Minor Surgery	0.0	± NA
Major Surgery	68.9	± 34.48
Oral Surgery	145.0	± NA
Von Willebrand Disease Type 1	122.5	± 31.82
Von Willebrand Disease Type 2A	50.0	± NA
Von Willebrand Disease Type 2B	100.0	± NA
Von Willebrand Disease Type 2M	100.0	± NA
Von Willebrand Disease Type 3	45.0	± 38.92

Intraoperative Actual Versus Predicted Blood Loss Score as Assessed by the Operating Surgeon Secondary · Day 0 (at completion of surgery)

Hemostatic efficacy will be rated on a scale of excellent - good - moderate - none. Excellent: Intraoperative blood loss was less than or equal to the maximum blood loss expected for the type of procedure performed in a hemostatically normal subject (≤ 100%). Good: Intraoperative blood loss was up to 50% more than the maximum expected blood loss for the type of procedure performed in a hemostatically normal subject (101-150%) Moderate: Intraoperative blood loss was more than 50% of the maximum expected blood loss for the type of procedure performed in a hemostatically normal subject (\>150%).

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	13
Minor Surgery	4
Major Surgery	8
Oral Surgery	1
Von Willebrand Disease Type 1	3
Von Willebrand Disease Type 2A	1
Von Willebrand Disease Type 2B	1
Von Willebrand Disease Type 2M	1
Von Willebrand Disease Type 3	7
Recombinant Von Willebrand Factor (rVWF)	2
Minor Surgery	0
Major Surgery	2
Oral Surgery	0
Von Willebrand Disease Type 1	0
Von Willebrand Disease Type 2A	1
Von Willebrand Disease Type 2B	0
Von Willebrand Disease Type 2M	0
Von Willebrand Disease Type 3	1
Recombinant Von Willebrand Factor (rVWF)	0
Minor Surgery	0
Major Surgery	0
Oral Surgery	0
Von Willebrand Disease Type 1	0
Von Willebrand Disease Type 2A	0
Von Willebrand Disease Type 2B	0
Von Willebrand Disease Type 2M	0
Von Willebrand Disease Type 3	0
Recombinant Von Willebrand Factor (rVWF)	0
Minor Surgery	0
Major Surgery	0
Oral Surgery	0
Von Willebrand Disease Type 1	0
Von Willebrand Disease Type 2A	0
Von Willebrand Disease Type 2B	0
Von Willebrand Disease Type 2M	0
Von Willebrand Disease Type 3	0

Intraoperative Hemostatic Efficacy Score as Assessed by the Operating Surgeon Secondary · Day 0 (at completion of surgery)

Hemostatic efficacy will be rated on a scale of excellent - good - moderate - none. Excellent: Intraoperative hemostasis achieved with rVWF with our without ADVATE was as good or better than that expected for the type of surgical procedure performed in a hemostatically normal subject. Good: Intraoperative hemostasis achieved with rVWF with or without ADVATE was probably as good as that expected for the type of surgical procedure performed in a hemostatically normal subject. Moderate: Intraoperative hemostasis with rVWF with or without ADVATE was clearly less than optimal for the type of proced

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	13
Minor Surgery	4
Major Surgery	8
Oral Surgery	1
Von Willebrand Disease Type 1	3
Von Willebrand Disease Type 2A	1
Von Willebrand Disease Type 2B	1
Von Willebrand Disease Type 2M	1
Von Willebrand Disease Type 3	7
Recombinant Von Willebrand Factor (rVWF)	2
Minor Surgery	0
Major Surgery	2
Oral Surgery	0
Von Willebrand Disease Type 1	0
Von Willebrand Disease Type 2A	1
Von Willebrand Disease Type 2B	0
Von Willebrand Disease Type 2M	0
Von Willebrand Disease Type 3	1
Recombinant Von Willebrand Factor (rVWF)	0
Minor Surgery	0
Major Surgery	0
Oral Surgery	0
Von Willebrand Disease Type 1	0
Von Willebrand Disease Type 2A	0
Von Willebrand Disease Type 2B	0
Von Willebrand Disease Type 2M	0
Von Willebrand Disease Type 3	0
Recombinant Von Willebrand Factor (rVWF)	0
Minor Surgery	0
Major Surgery	0
Oral Surgery	0
Von Willebrand Disease Type 1	0
Von Willebrand Disease Type 2A	0
Von Willebrand Disease Type 2B	0
Von Willebrand Disease Type 2M	0
Von Willebrand Disease Type 3	0

Daily Intra- and Postoperative Weight-adjusted Dose of rVWF With or Without ADVATE Secondary · Daily, from day of surgery through postoperative Day 14 (± 2 days)

intraoperative

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	18.1	18.1 – 18.1

postoperative day 1

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	23.5	16.9 – 47.2

postoperative day 2

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	42.3	23.2 – 50.6

postoperative day 3

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	28.6	20.6 – 48.9

postoperative day 4

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	33.9	23.2 – 44.3

postoperative day 5

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	31.5	18.8 – 47.2

postoperative day 6

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	23.2	18.8 – 23.6

postoperative day 7

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	23.8	23.6 – 50.8

Occurrence of Adverse Events Secondary · From first infusion of investigational product through study completion (ie, 14 (± 2) days post surgery)

Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) will be evaluated.

Treatment emergent Adverse Events (TEAEs)

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	12

Severe TEAEs

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	1

TEAEs related to rVWF

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	0

TEAEs related to ADVATE

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	0

TEAEs related to both rVWF and ADVATE

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	0

Treatment emergent Serious Adverse Events (TESAEs)

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	2

TESAEs related to rVWF

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	0

TESAEs related to ADVATE

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	0

Occurrence of Thrombotic Events Secondary · From first infusion of investigational product through study completion (ie, 14 (± 2) days post surgery)

Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) will be evaluated for thrombotic events.

Thrombotic TEAEs

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	2

Thrombotic TESAEs

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	1

Occurrence of Severe Allergic Reactions (eg, Anaphylaxis) Secondary · From first infusion of investigational product through study completion (ie, 14 (± 2) days post surgery)

Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) will be evaluated for severe allergic reactions.

Severe allergic reaction TEAEs

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	0

Severe allergic reaction TESAEs

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	0

Number of Participants Who Developed Inhibitory and Total Binding Antibodies to Von Willebrand Factor (VWF) and Inhibitory Antibodies to Factor VIII (FVIII) Secondary · Testing occurred throughout the study at screening, prior PK infusion, pre-surgery, post surgery in case of excessive bleeding or unexplained bleeding, at postoperative day 7 and at study completion visit (ie. 14 (± 2) days post surgery).

Participants were treated with recombinant van Willebrand Factor (rVWF) with or without ADVATE.

Development of inhibitory antibodies to VWF

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	0

Development of total binding antibodies to VWF

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	1

Development of inhibitory antibodies to FVIII

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	0

Number of Participants Who Developed Antibodies to Chinese Hamster Ovary (CHO) Proteins, Mouse Immunoglobulin G (IgG) or Recombinant Furin (rFurin) Secondary · Testing occurred throughout the study at screening, prior PK infusion, pre-surgery, post surgery in case of excessive bleeding or unexplained bleeding, at postoperative day 7 and at study completion visit (ie. 14 (± 2) days post surgery).

Participants were treated with recombinant van Willebrand Factor (rVWF) with or without ADVATE.

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	0

Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From 0 to 72 Hours Post-infusion (AUC 0-72 h/Dose) Secondary · PK measurements were done within 30 minutes pre-infusion, and post infusion at 30 (± 5) minutes, 60 (± 5) minutes, 6 (± 1) hours, 12 (± 1) hours, 24 (± 2) hours, 48 (± 2) hours and 72 (± 2) hours.

This assessment is only required for subjects undergoing major surgery. Subjects will receive a PK infusion at a dose of 50±5 IU/kg rVWF:RCo within 42 days prior to surgery. The area under the plasma concentration/time curve from 0 to 72 hours post-infusion will be computed using the linear trapezoidal rule. For the calculation of AUC(0-72h) the levels at 72 hours will be linearly interpolated/extrapolated from the 2 nearest sampling time points. PK analysis was performed for the following analytes: VWF Ristocetin Cofactor Activity (VWF:RCo), VWF Antigen Activity (VWF:Ag), VWF Collagen Binding

VWF:RCo

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	31.91	± 37.5

VWF:Ag

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	57.08	± 25.6

VWF:CB

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	63.91	± 29.4

VWF:Ac

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	54.61	± 28.1

FVIII:C

Group	Value	95% CI
Recombinant Von Willebrand Factor (rVWF)	67.49	± 31.1

Adverse events — posted to ClinicalTrials.gov

Time frame: Throughout the study period (from the first exposure to investigational product until study completion or discontinuation date). Total study duration: 1 year and 3 months. Per participant: up to 58 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Recombinant Von Willebrand Factor (rVWF)

Serious: 2/15 (13%)

Deaths: 0/15

Serious adverse events (2 terms)

Reaction	System	Recombinant Von Willebrand…
Diverticulitis	Infections and infestations	—
Deep vein thrombosis	Vascular disorders	—

Other adverse events (10 terms — click to expand)

Reaction	System	Recombinant Von Willebrand…
Acne	Skin and subcutaneous tissue disorders	—
Dry skin	Skin and subcutaneous tissue disorders	—
Iron deficiency anaemia	Blood and lymphatic system disorders	—
Peripheral swelling	General disorders	—
Nasopharyngitis	Infections and infestations	—
Joint swelling	Musculoskeletal and connective tissue disorders	—
Dizziness	Nervous system disorders	—
Headache	Nervous system disorders	—
Pelvic pain	Reproductive system and breast disorders	—
Deep vein thrombosis	Vascular disorders	—

Most-reported serious reactions: Diverticulitis, Deep vein thrombosis.

Data from ClinicalTrials.gov NCT02283268 adverse events section.

Sponsor's own description

The purpose of the study is to assess the efficacy and safety of recombinant von Willebrand factor (rVWF) with or without ADVATE in major and minor elective surgical procedures in adult patients with hereditary severe von Willebrand disease (VWD).

Publications & conference data

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

Phase 3 study of recombinant von Willebrand factor in patients with severe von Willebrand disease who are undergoing elective surgery.
Peyvandi F, Mamaev A, Wang JD, Stasyshyn O, et al · · 2019 · cited 53× · PMID 30362288 · DOI 10.1111/jth.14313
Pharmacokinetic-Pharmacodynamic Comparison of Recombinant and Plasma-Derived von Willebrand Factor in Patients with von Willebrand Disease Type 3.
Bauer A, Friberg-Hietala S, Smania G, Wolfsegger M. · · 2023 · cited 5× · PMID 37332615 · DOI 10.2147/jbm.s395845
Exposure-Response Relationship between VWF/FVIII Activity and Spontaneous Bleeding Events Following Recombinant VWF Prophylaxis in Severe VWD.
Leebeek FWG, Castaman G, Marier JF, Özen G, et al · · 2024 · cited 1× · PMID 38938750 · DOI 10.1055/s-0044-1787815
Recombinant von Willebrand factor for von Willebrand disease: mechanism of action and clinical application.
Hua Z, Miao W, Zhang P, Yang R. · · 2026 · PMID 41695782 · DOI 10.1177/20406207261419941
Bridging the Evidence Gap in von Willebrand Disease: A Call to Action for Equitable, Evidence-Based Care.
Uminski K, James P, Connell N, Khalife R. · · 2025 · PMID 40898807 · DOI 10.1111/hae.70123
Abstracts
· 2020

Verify or expand the search:

Other recruiting trials for Von Willebrand Disease

Currently open trials in the same condition.

NCT02932618 — A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Diseas · Phase 3 · recruiting

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 NCT02283268 (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: 19 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/NCT02283268.

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