Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02283268
Registration number
NCT02283268
Ethics application status
Date submitted
27/10/2014
Date registered
5/11/2014
Titles & IDs
Public title
Recombinant Von Willebrand Factor in Subjects With Severe Von Willebrand Disease Undergoing Surgery
Query!
Scientific title
A Phase 3, Prospective, Multicenter Study to Evaluate Efficacy and Safety of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Elective Surgical Procedures in Subjects With Severe Von Willebrand Disease
Query!
Secondary ID [1]
0
0
2014-003575-38
Query!
Secondary ID [2]
0
0
071101
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Von Willebrand Disease
0
0
Query!
Condition category
Condition code
Human Genetics and Inherited Disorders
0
0
0
0
Query!
Other human genetics and inherited disorders
Query!
Blood
0
0
0
0
Query!
Clotting disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Other - Recombinant von Willebrand Factor (rVWF)
Experimental: Recombinant von Willebrand Factor (rVWF) - Surgery participants treated with Recombinant von Willebrand Factor (rVWF)
Treatment: Other: Recombinant von Willebrand Factor (rVWF)
rVWF will be administered by intravenous bolus infusion. Participants planned for major surgery will undergo a baseline pharmacokinetic assessment prior to surgery. The peri- and postoperative substitution regimen will be individualized according to the PK results, intensity and duration of the hemostatic challenge, and the institution´s standard of care.
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Overall Hemostatic Efficacy as Assessed by the Investigator (Hemophilia Physician)
Query!
Assessment method [1]
0
0
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 than optimal for the type of procedure performed but was maintained without the need to change the rVWF concentrate. None: Participant experienced uncontrolled bleeding that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of rVWF concentrate.
Query!
Timepoint [1]
0
0
24 hours after last peri-operative infusion or at completion of Day 14 (± 2 days) visit, whichever occurs earlier
Query!
Secondary outcome [1]
0
0
Intraoperative Actual Versus Predicted Blood Loss as Assessed by the Operating Surgeon
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Day 0 (at completion of surgery)
Query!
Secondary outcome [2]
0
0
Intraoperative Actual Blood Loss Relative to Predicted Blood Loss
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Day 0 (at completion of surgery)
Query!
Secondary outcome [3]
0
0
Intraoperative Actual Versus Predicted Blood Loss Score as Assessed by the Operating Surgeon
Query!
Assessment method [3]
0
0
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%). None: Uncontrolled hemorrhage that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of clotting factor replacement regimen.
Query!
Timepoint [3]
0
0
Day 0 (at completion of surgery)
Query!
Secondary outcome [4]
0
0
Intraoperative Hemostatic Efficacy Score as Assessed by the Operating Surgeon
Query!
Assessment method [4]
0
0
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 procedure performed but was maintained without the need to change the rVWF concentrate. None: Participant experienced uncontrolled bleeding that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of rVWF concentrate.
Query!
Timepoint [4]
0
0
Day 0 (at completion of surgery)
Query!
Secondary outcome [5]
0
0
Daily Intra- and Postoperative Weight-adjusted Dose of rVWF With or Without ADVATE
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Daily, from day of surgery through postoperative Day 14 (± 2 days)
Query!
Secondary outcome [6]
0
0
Occurrence of Adverse Events
Query!
Assessment method [6]
0
0
Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) will be evaluated.
Query!
Timepoint [6]
0
0
From first infusion of investigational product through study completion (ie, 14 (± 2) days post surgery)
Query!
Secondary outcome [7]
0
0
Occurrence of Thrombotic Events
Query!
Assessment method [7]
0
0
Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) will be evaluated for thrombotic events.
Query!
Timepoint [7]
0
0
From first infusion of investigational product through study completion (ie, 14 (± 2) days post surgery)
Query!
Secondary outcome [8]
0
0
Occurrence of Severe Allergic Reactions (eg, Anaphylaxis)
Query!
Assessment method [8]
0
0
Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) will be evaluated for severe allergic reactions.
Query!
Timepoint [8]
0
0
From first infusion of investigational product through study completion (ie, 14 (± 2) days post surgery)
Query!
Secondary outcome [9]
0
0
Number of Participants Who Developed Inhibitory and Total Binding Antibodies to Von Willebrand Factor (VWF) and Inhibitory Antibodies to Factor VIII (FVIII)
Query!
Assessment method [9]
0
0
Participants were treated with recombinant van Willebrand Factor (rVWF) with or without ADVATE.
Query!
Timepoint [9]
0
0
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).
Query!
Secondary outcome [10]
0
0
Number of Participants Who Developed Antibodies to Chinese Hamster Ovary (CHO) Proteins, Mouse Immunoglobulin G (IgG) or Recombinant Furin (rFurin)
Query!
Assessment method [10]
0
0
Participants were treated with recombinant van Willebrand Factor (rVWF) with or without ADVATE.
Query!
Timepoint [10]
0
0
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).
Query!
Secondary outcome [11]
0
0
Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From 0 to 72 Hours Post-infusion (AUC 0-72 h/Dose)
Query!
Assessment method [11]
0
0
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 Activity (VWF:CB), VWF Activity Measured INNOVANCE VWF Ac Assay (VWF:Ac), FVIII Coagulation Activity (FVIII:C)
Query!
Timepoint [11]
0
0
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.
Query!
Secondary outcome [12]
0
0
Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUC 0-8 /Dose)
Query!
Assessment method [12]
0
0
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 time 0 to infinity and the area under the first moment curve from time 0 to infinity will be calculated as the sum of AUC or AUMC from time 0 to the time of last quantifiable concentration plus a tail area correction calculated as Ct/?z and Ct/?z(t+1/?z), respectively, where Ct is the last quantifiable concentration, t is the time of last quantifiable concentration and ?z is the terminal or disposition rate constant. PK analysis was performed for the following analytes: VWF Ristocetin Cofactor Activity (VWF:RCo), VWF Antigen Activity (VWF:Ag), VWF Collagen Binding Activity (VWF:CB), VWF Activity Measured INNOVANCE VWF Ac Assay (VWF:Ac), FVIII Coagulation Activity (FVIII:C)
Query!
Timepoint [12]
0
0
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.
Query!
Secondary outcome [13]
0
0
Pharmacokinetics: Mean Residence Time (MRT)
Query!
Assessment method [13]
0
0
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. Mean residence time will be calculated as area under the first moment curve from time 0 to infinity divided by the area under the curve time 0 to infinity minus T/2 where T is the duration of the infusion. PK analysis was performed for the following analytes: VWF Ristocetin Cofactor Activity (VWF:RCo), VWF Antigen Activity (VWF:Ag), VWF Collagen Binding Activity (VWF:CB), VWF Activity Measured INNOVANCE VWF Ac Assay (VWF:Ac)
Query!
Timepoint [13]
0
0
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.
Query!
Secondary outcome [14]
0
0
Pharmacokinetics: Clearance (CL)
Query!
Assessment method [14]
0
0
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. Clearance will be calculated as dose (IU/kg) divided by the area under the curve time 0 to infinity. PK analysis was performed for the following analytes: VWF Ristocetin Cofactor Activity (VWF:RCo), VWF Antigen Activity (VWF:Ag), VWF Collagen Binding Activity (VWF:CB), VWF Activity Measured INNOVANCE VWF Ac Assay (VWF:Ac)
Query!
Timepoint [14]
0
0
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.
Query!
Secondary outcome [15]
0
0
Pharmacokinetics: Incremental Recovery (IR)
Query!
Assessment method [15]
0
0
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. Incremental recovery will be calculated as (Cmax minus Cpreinfusion) divided by the dose (IU/kg) where kg refers to the body weight at the time of dosing and Cmax is the observed maximum concentration before correction for pre-infusion values. PK analysis was performed for the following analytes: VWF Ristocetin Cofactor Activity (VWF:RCo), VWF Antigen Activity (VWF:Ag), VWF Collagen Binding Activity (VWF:CB), VWF Activity Measured INNOVANCE VWF Ac Assay (VWF:Ac)
Query!
Timepoint [15]
0
0
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.
Query!
Secondary outcome [16]
0
0
Pharmacokinetics: Elimination Phase Half-life (T1/2)
Query!
Assessment method [16]
0
0
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. Terminal or disposition half-life (T1/2) will be calculated as ln2/?z where ?z is the terminal elimination rate constant as calculated in WinNonlin NCA using at least three quantifiable concentrations. PK analysis was performed for the following analytes: VWF Ristocetin Cofactor Activity (VWF:RCo), VWF Antigen Activity (VWF:Ag), VWF Collagen Binding Activity (VWF:CB), VWF Activity Measured INNOVANCE VWF Ac Assay (VWF:Ac)
Query!
Timepoint [16]
0
0
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.
Query!
Secondary outcome [17]
0
0
Pharmacokinetics: Volume of Distribution at Steady State (Vss)
Query!
Assessment method [17]
0
0
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. Vss will be calculated as the clearance multiplied with the mean residence time. PK analysis was performed for the following analytes: VWF Ristocetin Cofactor Activity (VWF:RCo), VWF Antigen Activity (VWF:Ag), VWF Collagen Binding Activity (VWF:CB), VWF Activity Measured INNOVANCE VWF Ac Assay (VWF:Ac)
Query!
Timepoint [17]
0
0
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.
Query!
Eligibility
Key inclusion criteria
* Diagnosis of severe von Willebrand disease (VWD) as listed below and elective surgical procedure planned
1. Type 1 (Von Willebrand factor : Ristocetin cofactor activity (VWF:RCo) <20 IU/dL), or
2. Type 2A (as verified by multimer pattern), Type 2B (as diagnosed by genotype), Type 2N (FVIII:C<10% and historically documented genetics), Type 2M, or
3. Type 3 (Von Willebrand factor antigen (VWF:Ag) = 3 IU/dL)
* VWD with a history of requiring substitution therapy with von Willebrand factor (VWF) concentrate to control bleeding
* If type 3 VWD (VWF Antigen /VWF:Ag = 3 IU/dL), participant has a medical history of at least 20 exposure days to VWF/FVIII coagulation factor concentrates (including cryoprecipitate or fresh frozen plasma)
* If type 1 or type 2 VWD, participant has a medical history of 5 exposure days or a past major surgery requiring VWF/FVIII coagulation factor concentrates (including cryoprecipitate or fresh frozen plasma)
* Participant is at least 18 years of age
* If female of childbearing potential, participant presents with a negative pregnancy test
* If applicable, participant agrees to employ adequate birth control measures for the duration of the study
* Participant is willing and able to comply with the requirements of the protocol
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Diagnosis of pseudo VWD or another hereditary or acquired coagulation disorder (eg, qualitative and quantitative platelet disorders or elevated prothrombin time [PT] / international normalized ratio [INR] > 1.4)
* History or presence of a VWF inhibitor at screening
* History or presence of a factor VIII (FVIII) inhibitor with a titer = 0.4 BU (Nijmegen-modified Bethesda assay ) or = 0.6 BU (by Bethesda assay)
* Known hypersensitivity to any of the components of the study drugs, such as to mouse or hamster proteins
* Medical history of immunological disorders, excluding seasonal allergic rhinitis/conjunctivitis, mild asthma, food allergies or animal allergies
* Medical history of a thromboembolic event
* HIV positive with an absolute CD4 count < 200/mm3
* Platelet count < 100,000/mL
* Diagnosis of significant liver disease, as evidenced by, but not limited to, any of the following: serum alanine aminotransferase (ALT) 5 times the upper limit of normal; hypoalbuminemia; portal vein hypertension (eg. presence of otherwise unexplained splenomegaly, history of esophageal varices) or liver cirrhosis classified as Child B or C
* Diagnosis of renal disease, with a serum creatinine level = 2 .5mg/dL
* Participant has been treated with an immunomodulatory drug, excluding topical treatment (eg, ointments, nasal sprays), within 30 days prior to signing the informed consent
* Participant is pregnant or lactating at the time informed content is obtained
* Participant has participated in another clinical study involving an investigational product (IP), other than rVWF with or without ADVATE, 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. However, eligible patients participating in the rVWF Prophylaxis Study (071301) may be enrolled.
* Progressive fatal disease and/or life expectancy of less than 3 months
* Participant is identified by the investigator as being unable or unwilling to cooperate with study procedures
* Participant suffers from a mental condition rendering him/her unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude
* Participant is in prison or compulsory detention by regulatory and/or juridical order
* Participant is a member of the study team conducting this study or 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/04/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
6/07/2016
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
24
Query!
Recruitment in Australia
Recruitment state(s)
SA,WA
Query!
Recruitment hospital [1]
0
0
Royal Adelaide Hospital - Adelaide
Query!
Recruitment hospital [2]
0
0
The Perth Blood Institute - Nedlands
Query!
Recruitment hospital [3]
0
0
Fiona Stanley Hospital - Perth
Query!
Recruitment postcode(s) [1]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [2]
0
0
6009 - Nedlands
Query!
Recruitment postcode(s) [3]
0
0
6000 - Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Colorado
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Georgia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Maryland
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Massachusetts
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
New Jersey
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
North Carolina
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Ohio
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Oklahoma
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
South Carolina
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Wisconsin
Query!
Country [12]
0
0
Austria
Query!
State/province [12]
0
0
Vienna
Query!
Country [13]
0
0
Czechia
Query!
State/province [13]
0
0
Ostrava
Query!
Country [14]
0
0
Germany
Query!
State/province [14]
0
0
Rheinland-Pfalz
Query!
Country [15]
0
0
Italy
Query!
State/province [15]
0
0
Firenze (Florence)
Query!
Country [16]
0
0
Italy
Query!
State/province [16]
0
0
Milano
Query!
Country [17]
0
0
Italy
Query!
State/province [17]
0
0
Rome
Query!
Country [18]
0
0
Netherlands
Query!
State/province [18]
0
0
Rotterdam
Query!
Country [19]
0
0
Russian Federation
Query!
State/province [19]
0
0
Barnaul
Query!
Country [20]
0
0
Russian Federation
Query!
State/province [20]
0
0
Kirov
Query!
Country [21]
0
0
Spain
Query!
State/province [21]
0
0
A Coruña
Query!
Country [22]
0
0
Spain
Query!
State/province [22]
0
0
Valencia
Query!
Country [23]
0
0
Taiwan
Query!
State/province [23]
0
0
Taichung
Query!
Country [24]
0
0
Taiwan
Query!
State/province [24]
0
0
Taipei
Query!
Country [25]
0
0
Turkey
Query!
State/province [25]
0
0
Izmir
Query!
Country [26]
0
0
Ukraine
Query!
State/province [26]
0
0
Lviv
Query!
Country [27]
0
0
United Kingdom
Query!
State/province [27]
0
0
Devon
Query!
Country [28]
0
0
United Kingdom
Query!
State/province [28]
0
0
Greater London
Query!
Country [29]
0
0
United Kingdom
Query!
State/province [29]
0
0
Oxfordshire
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Baxalta now part of Shire
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
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).
Query!
Trial website
https://clinicaltrials.gov/study/NCT02283268
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Study Director
Query!
Address
0
0
Takeda
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02283268