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.
Ratio of Annualized Bleeding Rate (ABR) for Spontaneous Bleeding Episodes (BEs) (On-study ABR / Historical ABR) Assessed by Investigator During Prophylactic Treatment With rVWF Through Month 12Primary· Up to 12 months
ABR for treated spontaneous BEs while on prophylactic treatment with rVWF through month 12 of treatment period/observation period (in years), where an observation period = (date of completion/termination - date of first dose + 1)/365.2425. Bleeds occurred at the same anatomical location with the same etiology within 24 hours after onset of the first bleed were considered a single bleed. Bleeding occurred at multiple locations related to the same injury were considered as a single bleeding episode. Historical observation period for historical BEs was 365 days prior to first dose of study drug.
Group
Value
95% CI
Prior On-demand Participants
0.085
0.021 – 0.346
Switch Participants
0.550
0.086 – 3.523
Percentage of Prior On-demand Participants Achieved Spontaneous ABR Percent Reduction Success Through Month 12Secondary· Up to 12 months
For prior on-demand participants, spontaneous ABR percent reduction success was defined as at least 25% reduction of the ABR for treated spontaneous (not related to trauma) BEs during the first 12 months of rVWF (vonicog alfa) prophylaxis relative to the participant's own historical treated spontaneous ABR. Percentage of participants with ABR percent reduction success for on-demand cohort was reported.
Group
Value
95% CI
Prior On-demand Participants
92.3
64.0 – 99.8
Percentage of Switch Participants With Spontaneous ABR Preservation Success Through Month 12Secondary· Up to 12 months
For switch participants, spontaneous ABR preservation success was defined as achieving an ABR for treated spontaneous BEs during first 12 months of rVWF (vonicog alfa) prophylaxis that was no greater than the participant's own historical ABR for treated spontaneous BEs during prophylactic treatment with pdVWF. Percentage of participants with ABR preservation success in switch cohort was reported.
Group
Value
95% CI
Switch Participants
90.0
55.5 – 99.7
Number of Participants Based on Categorized Spontaneous ABR (sABR) Through Month 12Secondary· Baseline through Month 12
The sABR was the number of spontaneous bleeds divided by the observation period in years, where an observation period = (date of completion/termination-date of first dose+1)/365.2425.sABR was categorized based on number of BEs as 0, greater than (\>) 0 through 2,\>2 through 5,\>5 during the prophylactic treatment with rVWF (vonicog alfa) through 12 months. Bleeding at multiple locations related to the same injury was counted as single bleeding episode. BEs of unknown cause were counted as spontaneous bleeds. Observation period for historical BEs was 365 days prior to first dose of study drug.
Historical
Group
Value
95% CI
Prior On-demand Participants
0
Switch Participants
6
Prior On-demand Participants
0
Switch Participants
3
Prior On-demand Participants
10
Switch Participants
0
Prior On-demand Participants
3
Switch Participants
1
On-Study Through Month 12
Group
Value
95% CI
Prior On-demand Participants
11
Switch Participants
7
Prior On-demand Participants
0
Switch Participants
1
Prior On-demand Participants
1
Switch Participants
1
Prior On-demand Participants
1
Switch Participants
1
Total Number of Infusions Administered Per Participant During Prophylactic Treatment With rVWF Through Month 12Secondary· Up to 12 months
For each participant, the total number of infusions was counted as the total number of unique infusions of rVWF which were administered between the dates of informed consent and termination from the study, inclusive, regardless of the date and time of administration. The total number of infusions administered during the study was entered in electronic case record form (eCRF), and recorded in ERT system. Total number of infusions administered per participant during prophylactic treatment With rVWF through 12 months was calculated.
Group
Value
95% CI
Prior On-demand Participants
65.1
± 38.4
Switch Participants
87.8
± 30.2
Average Number of Infusions Per Week Per Participant During Prophylactic Treatment With rVWF Through Month 12Secondary· Up to 12 months
Average number of infusions per week per participant during prophylactic treatment With rVWF through 12 months was calculated.
Group
Value
95% CI
Prior On-demand Participants
1.88
± 0.7
Switch Participants
1.85
± 0.4
Total Weight Adjusted Consumption of rVWF Per Participant During Prophylactic Treatment Through Month 12Secondary· Up to 12 months
For each participant, the body weight-adjusted dose (IU/kg) was derived as the number of units of rVWF infused (IU) divided by the last available body weight (kilogram \[kg\]) prior to the infusion. Total weight adjusted consumption of rVWF (vonicog alfa) per participant during prophylactic treatment was reported.
Group
Value
95% CI
Prior On-demand Participants
3431.584
± 2117.6562
Switch Participants
4433.752
± 1844.8761
Number of Treated Spontaneous BEs by Location of Bleeding While on Prophylactic Treatment With rVWF Through Month 12Secondary· Up to 12 months
Number of treated spontaneous BEs by location of bleeding (for example: oral and other mucosa, menorrhagia, hemarthrosis, etc.) while on prophylactic treatment with rVWF was reported.
Oral and other mucosa
Group
Value
95% CI
Prior On-demand Participants
5
Switch Participants
14
Menorrhagia
Group
Value
95% CI
Prior On-demand Participants
3
Switch Participants
0
Hemarthrosis
Group
Value
95% CI
Prior On-demand Participants
0
Switch Participants
1
Other
Group
Value
95% CI
Prior On-demand Participants
1
Switch Participants
0
Unknown
Group
Value
95% CI
Prior On-demand Participants
0
Switch Participants
3
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious TEAEsSecondary· From first dose of study drug up to end of study (approximately 32 months)
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered IP that does not necessarily have a causal relationship with the treatment. TEAEs were events which occurred on or after the date and time of administration of the first dose of study medication. TEAEs included both serious AEs and non-serious AEs. Number of participants with TEAEs and serious TEAEs were reported.
Participants With TEAEs
Group
Value
95% CI
Prior On-demand Participants
10
Switch Participants
7
Participants with serious TEAEs
Group
Value
95% CI
Prior On-demand Participants
1
Switch Participants
2
Number of Participants Based on Severity of TEAEsSecondary· From first dose of study drug up to end of study (approximately 32 months)
An AE is defined as any untoward medical occurrence in a participant administered IP that does not necessarily have a causal relationship with the treatment. TEAEs were events which occurred on or after the date and time of administration of the first dose of study medication. TEAEs included both serious AEs and non-serious AEs. Severity of TEAEs was determined by following definitions: Mild: No limitation of usual activities; Moderate: Some limitation of usual activities and may required therapeutic intervention; Severe: Inability to carry out usual activities with sequelae, which required th
Mild
Group
Value
95% CI
Prior On-demand Participants
7
Switch Participants
4
Moderate
Group
Value
95% CI
Prior On-demand Participants
1
Switch Participants
2
Severe
Group
Value
95% CI
Prior On-demand Participants
2
Switch Participants
1
Number of Participants With TEAEs Based CausalitySecondary· From first dose of study drug up to end of study (approximately 32 months)
An AE was defined as any untoward medical occurrence in a participant administered IP that does not necessarily have a causal relationship with the treatment. TEAEs were events which occurred on or after the date and time of administration of the first dose of study medication. TEAEs included both serious AEs and non-serious AEs. For each AE, the investigator assessed the causal relationship between the IP and the AE based on clinical expertise and judgment according to the following circumstances of the AE: Not related, Unlikely related, Possibly related, or Probably related. A related TEAE w
Group
Value
95% CI
Prior On-demand Participants
1
Switch Participants
0
Number of Participants With Thromboembolic EventsSecondary· From first dose of study drug up to end of study (approximately 32 months)
Thromboembolism defined as formation in a blood vessel of a clot (thrombus) that breaks loose and carried by the blood stream and could plug another vessel. Number of participants with thromboembolic events as TEAEs of special interest was reported. A broad standard search query approach was used (broad SMQ) to identify all potential thromboembolic events of interest which were then medically assessed. Number of participants with thromboembolic events as TEAEs of special interest was reported.
Group
Value
95% CI
Prior On-demand Participants
1
Switch Participants
0
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study drug up to end of study (approximately 32 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this phase 3 study is to investigate the efficacy and safety, including immunogenicity, thrombogenicity and hypersensitivity reactions, as well as pharmacokinetics (PK), health related quality of life (HRQoL) and pharmacoeconomics of prophylactic treatment with recombinant von Willebrand factor (rVWF) (vonicog alfa) in adult participants with severe von Willebrand disease (VWD).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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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 Takeda
Last refreshed: 6 August 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/NCT02973087.