Von Willebrand DiseasePhase 4NCT02472665
Efficacy and Safety of Fanhdi®, a High-purity Von Willebrand Containing FVIII Concentrate, in Pediatric Patients With Von Willebrand Disease
A Phase 4 study testing plasma-derived FVIII/VWF concentrate in people with Von Willebrand Disease, run by Grifols Therapeutics LLC at 4 sites in Spain.
Trial summary
Multicenter, prospective, non-controlled study in a pediatric cohort (<6 years-old) with severe (type 2 or 3) hereditary Von Willebrand Disease (VWD). Read more about this study
- Who is it for?
- Ages 2 months to 6 years
- Conditions the study is for
- Von Willebrand Disease
- What is being tested?
- plasma-derived FVIII/VWF concentrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesSpain
- Study dates
- Dec 2013to 10 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects diagnosed with severe (type 2 or 3) hereditary VWD (VWF:RCo<15-20 IU/dL), or VWF:Act<15-20 IU/dL.
- Subjects under 6 years of age.
- Signed informed consent form (ICF) provided by an authorized representative on behalf of the subject in accordance with local law and institutional policy.
Who cannot join
- Subjects diagnosed with acquired VWD.
- Subjects with active bleeding at the time of the first infusion or within 10 days prior to the infusion.
- Subjects who have been treated with DDAVP or another FVIII containing VWF concentrate during the 5 days prior to the infusion of the Fanhdi. This treatment-free period may be reduced to 3 days for subjects with type 3 VWD.
- Subject who are positive for anti-VWF or anti-FVIII antibodies (≥0.5 Bethesda Units) or has been positive in the history of their disease.
- Subjects with a known allergies/intolerance to any substance contained in Fanhdi.
- Subjects with a known history of anaphylactic reaction(s) to blood or blood components.
Show all 13Show fewer
- Subjects presenting severe platelet activity dysfunction due to the use of drugs (aspirin, other nonsteroidal anti-inflammatory drugs [NSAIDs], etc.) or a congenital or acquired platelet function disorder or other concomitant processes that may interfere with coagulation.
- Subjects have a known previous infection with hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV), or have clinical signs and symptoms consistent with current HAV, HBV, HCV or HIV infection.
- Subjects presenting anemia (hemoglobin <11 g/dL).
- Subjects diagnosed with metabolic diseases that are not clinically controlled, such as diabetes mellitus, which could potentially interfere with the interpretations of the study.
- Participated in another clinical trial within 30 days prior to the screening visit or has received any investigational product (IP) within 3 months prior to the screening visit.
- If it is anticipated that the subject will be treated with other products containing FVIII or VWF different from Fanhdi throughout the subject's participation.
- Subjects who, in the opinion of the investigator, may have compliance problems with the protocol.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital Sant Joan de Déu Barcelona
Esplugues de Llobregat, Barcelona, 08950
Hospital Universitario La Paz
Madrid
Hospital Universitario Virgen del Rocío
Seville, Sevilla, 41013
Hospital Universitario Miguel Servet
Zaragoza
About this study
Official title: Evaluation of the Pharmacokinetic Profile, Clinical Efficacy and Safety of the Von Willebrand Factor Contained in FANHDI® (Double-inactivated Human Anti-hemophilic Factor) in Pediatric Subjects With Severe Von Willebrand Disease
Multicenter, prospective, non-controlled study in a pediatric cohort (<6 years-old) with severe (type 2 or 3) hereditary Von Willebrand Disease (VWD).
Read the detailed description
This is a multicenter, prospective, open-label, and single-arm study. The study population is planned to include 8 pediatric subjects (<6 years of age) with severe (type 2 or 3) hereditary VWD without inhibitors and with no active bleeding at the time of inclusion. Eligible subjects will receive a single dose of Fanhdi for a PK evaluation and will be followed for 12 months for which the efficacy and safety of Fanhdi will be assessed. In addition, the type 3 VWD subjects, after 6 months of follow-up of the first infusion, will receive the second dose as in the 1st PK evaluation and undergo a 2nd PK evaluation.
The study will consist of 2 phases:
- PK profile evaluation in which all eligible subjects will receive a single dose of 80 IU/kg von Willebrand factor: Ristocetin cofactor activity (VWF:RCo) of Fanhdi. In addition, after 6 months of follow-up of the first infusion, type 3 VWD subjects will receive the second dose of Fanhdi and undergo a 2nd PK evaluation with a reduced sampling schedule.
- A 12-month Follow-up period during which the safety and efficacy of Fanhdi will be assessed in the prevention and management of bleeding episodes and/or management of perioperative hemostasis during surgery and/or invasive procedures.
- Conditions
- Von Willebrand Disease
- Being tested
- plasma-derived FVIII/VWF concentrate
- Keywords
- pediatric, plasma-derived FVIII concentrate
- Medical subject headings
- von Willebrand Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plasma-derived FVIII/VWF concentrateDrug
Also called Fanhdi
1 single dose of 80 IU/kg VWF:RCo of Fanhdi will be administered
| Study group | Role | What they receive |
|---|---|---|
| plasma-derived FVIII/VWF concentrate | Experimental | Pharmacokinetic single dose study with Fanhdi (high-purity Von Willebrand containing FVIII concentrate) Receives: Drug: plasma-derived FVIII/VWF concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC^0-inf of coagulation factor VIII activity (FVIII:C)
Cumulative area under the concentration time curve extrapolated to infinity of FVIII:C
Measured: Prior to the first infusion up to 72 hours postinfusion
AUC^0-inf of von Willebrand factor: Ristocetin cofactor activity (VWF:RCo)
Cumulative area under the concentration time curve extrapolated to infinity of VWF:RCo
Measured: Prior to the first infusion up to 72 hours postinfusion
AUC^0-inf of von Willebrand factor antigen (VWF:Ag)
Cumulative area under the concentration time curve extrapolated to infinity of VWF:Ag
Measured: Prior to the first infusion up to 72 hours postinfusion
AUC^0-inf of von Willebrand factor: Collagen binding activity (VWF:CB)
Cumulative area under the concentration time curve extrapolated to infinity of VWF:CB
Measured: Prior to the first infusion up to 72 hours postinfusion
AUC^0-T of FVIII:C
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration of FVIII:C
Measured: Prior to the first infusion up to 72 hours postinfusion
AUC^0-T of VWF:RCo
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration of VWF:RCo
Measured: Prior to the first infusion up to 72 hours postinfusion
AUC^0-T of VWF:Ag
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration of VWF:Ag
Measured: Prior to the first infusion up to 72 hours postinfusion
AUC^0-T of VWF:CB
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration of VWF:CB
Measured: Prior to the first infusion up to 72 hours postinfusion
in vivo recovery of FVIII:C
Measured: Prior to the first infusion up to 72 hours postinfusion
in vivo recovery of VWF:RCo
Measured: Prior to the first infusion up to 72 hours postinfusion
in vivo recovery of VWF:Ag
Measured: Prior to the first infusion up to 72 hours postinfusion
in vivo recovery of VWF:CB
Measured: Prior to the first infusion up to 72 hours postinfusion
Half-life of FVIII:C
Terminal elimination half-life
Measured: Prior to the first infusion up to 72 hours postinfusion
Half-life of VWF:RCo
Terminal elimination half-life
Measured: Prior to the first infusion up to 72 hours postinfusion
Half-life of VWF:Ag
Terminal elimination half-life
Measured: Prior to the first infusion up to 72 hours postinfusion
C^max of FVIII:C
Maximum observed plasma and/or serum concentration of FVIII:C
Measured: Prior to the first infusion up to 72 hours postinfusion
C^max of VWF:RCo
Maximum observed plasma and/or serum concentration of VWF:RCo
Measured: Prior to the first infusion up to 72 hours postinfusion
C^max of VWF:Ag
Maximum observed plasma and/or serum concentration of VWF:Ag
Measured: Prior to the first infusion up to 72 hours postinfusion
C^max of VWF:CB
Maximum observed plasma and/or serum concentration of VWF:CB
Measured: Prior to the first infusion up to 72 hours postinfusion
T^max of FVIII:C
Time of maximum observed plasma and/or serum concentration of FVIII:C
Measured: Prior to the first infusion up to 72 hours postinfusion
T^max of VWF:RCo
Time of maximum observed plasma and/or serum concentration of VWF:RCo
Measured: Prior to the first infusion up to 72 hours postinfusion
T^max of VWF:Ag
Time of maximum observed plasma and/or serum concentration of VWF:Ag
Measured: Prior to the first infusion up to 72 hours postinfusion
T^max of VWF:CB
Time of maximum observed plasma and/or serum concentration of VWF:CB
Measured: Prior to the first infusion up to 72 hours postinfusion
Mean residence time of FVIII:C
Average amount of time that a single molecule of drug stays in the body.
Measured: Prior to the first infusion up to 72 hours postinfusion
Mean residence time of VWF:RCo
Average amount of time that a single molecule of drug stays in the body of VWF:RCo
Measured: Prior to the first infusion up to 72 hours postinfusion
Mean residence time of VWF:Ag
Average amount of time that a single molecule of drug stays in the body of VWF:Ag
Measured: Prior to the first infusion up to 72 hours postinfusion
Mean residence time of VWF:CB
Average amount of time that a single molecule of drug stays in the body of VWF:CB
Measured: Prior to the first infusion up to 72 hours postinfusion
Clearance of FVIII:C
Total plasma and/or serum clearance
Measured: Prior to the first infusion, 30 minutes postinfusion, 10 hours postinfusion, and at 24, 48, and 72 hours postinfusion
Clearance of VWF:RCo
Total plasma and/or serum clearance
Measured: Prior to the first infusion, 30 minutes postinfusion, 10 hours postinfusion, and at 24, 48, and 72 hours postinfusion
Clearance of VWF:Ag
Total plasma and/or serum clearance
Measured: Prior to the first infusion, 30 minutes postinfusion, 10 hours postinfusion, and at 24, 48, and 72 hours postinfusion
Clearance of VWF:CB
Total plasma and/or serum clearance
Measured: Prior to the first infusion, 30 minutes postinfusion, 10 hours postinfusion, and at 24, 48, and 72 hours postinfusion
Elimination rate constant of FVIII:C
Measured: Prior to the first infusion up to 72 hours postinfusion
Elimination rate constant of VWF:RCo
Measured: Prior to the first infusion up to 72 hours postinfusion
Elimination rate constant of VWF:Ag
Measured: Prior to the first infusion up to 72 hours postinfusion
Elimination rate constant of VWF:CB
Measured: Prior to the first infusion up to 72 hours postinfusion
Volume of distribution of FVIII:C
Measured: Prior to the first infusion up to 72 hours postinfusion
Volume of distribution of VWF:RCo
Measured: Prior to the first infusion up to 72 hours postinfusion
Volume of distribution of VWF:Ag
Measured: Prior to the first infusion up to 72 hours postinfusion
Volume of distribution of VWF:CB
Measured: Prior to the first infusion up to 72 hours postinfusion
VWF multimeric pattern
For type 3 VWD subjects
Measured: Prior to the first infusion up to 12 hours postinfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study startDec 2013
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Why it stopped: Due to recruitment difficulties for pediatric patients. The reason for study cancellation is not related to safety concerns or any adverse events.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Von Willebrand DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grifols Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Instituto Grifols, S.A.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02472665
- Sponsor's protocol ID
- IG1005
- Status last verified
- May 2026
- First submitted
- 10 Jun 2015
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Pharmacokinetic Profile, Clinical Efficacy and Safety of the Von Willebrand Factor Contained in FANHDI® (Double-inactivated Human Anti-hemophilic Factor) in Pediatric Subjects With Severe Von Willebrand Disease
- ClinicalTrials.gov ID
- NCT02472665
- Acronym / sponsor ID
- IG1005
- Conditions
- Von Willebrand Disease
- Keywords
- pediatric, plasma-derived FVIII concentrate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to recruitment difficulties for pediatric patients. The reason for study cancellation is not related to safety concerns or any adverse events.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Grifols Therapeutics LLCIndustry (pharma, biotech, devices)
- Collaborators
- Instituto Grifols, S.A.
- Study start
- Dec 2013
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 16 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter, prospective, non-controlled study in a pediatric cohort (<6 years-old) with severe (type 2 or 3) hereditary Von Willebrand Disease (VWD).
Detailed description
This is a multicenter, prospective, open-label, and single-arm study. The study population is planned to include 8 pediatric subjects (<6 years of age) with severe (type 2 or 3) hereditary VWD without inhibitors and with no active bleeding at the time of inclusion. Eligible subjects will receive a single dose of Fanhdi for a PK evaluation and will be followed for 12 months for which the efficacy and safety of Fanhdi will be assessed. In addition, the type 3 VWD subjects, after 6 months of follow-up of the first infusion, will receive the second dose as in the 1st PK evaluation and undergo a 2nd PK evaluation.
The study will consist of 2 phases:
- PK profile evaluation in which all eligible subjects will receive a single dose of 80 IU/kg von Willebrand factor: Ristocetin cofactor activity (VWF:RCo) of Fanhdi. In addition, after 6 months of follow-up of the first infusion, type 3 VWD subjects will receive the second dose of Fanhdi and undergo a 2nd PK evaluation with a reduced sampling schedule.
- A 12-month Follow-up period during which the safety and efficacy of Fanhdi will be assessed in the prevention and management of bleeding episodes and/or management of perioperative hemostasis during surgery and/or invasive procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| plasma-derived FVIII/VWF concentrate | Experimental | Drug: plasma-derived FVIII/VWF concentratePharmacokinetic single dose study with Fanhdi (high-purity Von Willebrand containing FVIII concentrate) |
Who may qualify
- Ages
- 2 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Subjects diagnosed with severe (type 2 or 3) hereditary VWD (VWF:RCo<15-20 IU/dL), or VWF:Act<15-20 IU/dL.
- Subjects under 6 years of age.
- Signed informed consent form (ICF) provided by an authorized representative on behalf of the subject in accordance with local law and institutional policy.
Key exclusion criteria (13 listed)
- Subjects diagnosed with acquired VWD.
- Subjects with active bleeding at the time of the first infusion or within 10 days prior to the infusion.
- Subjects who have been treated with DDAVP or another FVIII containing VWF concentrate during the 5 days prior to the infusion of the Fanhdi. This treatment-free period may be reduced to 3 days for subjects with type 3 VWD.
- Subject who are positive for anti-VWF or anti-FVIII antibodies (≥0.5 Bethesda Units) or has been positive in the history of their disease.
- Subjects with a known allergies/intolerance to any substance contained in Fanhdi.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plasma-derived FVIII/VWF concentrateAlso: Fanhdi1 single dose of 80 IU/kg VWF:RCo of Fanhdi will be administered | Drug | plasma-derived FVIII/VWF concentrate |
Primary outcome
AUC^0-inf of coagulation factor VIII activity (FVIII:C)
Time frame: Prior to the first infusion up to 72 hours postinfusion
Cumulative area under the concentration time curve extrapolated to infinity of FVIII:C
AUC^0-inf of von Willebrand factor: Ristocetin cofactor activity (VWF:RCo)
Time frame: Prior to the first infusion up to 72 hours postinfusion
Cumulative area under the concentration time curve extrapolated to infinity of VWF:RCo
AUC^0-inf of von Willebrand factor antigen (VWF:Ag)
Time frame: Prior to the first infusion up to 72 hours postinfusion
Cumulative area under the concentration time curve extrapolated to infinity of VWF:Ag
AUC^0-inf of von Willebrand factor: Collagen binding activity (VWF:CB)
Time frame: Prior to the first infusion up to 72 hours postinfusion
Cumulative area under the concentration time curve extrapolated to infinity of VWF:CB
AUC^0-T of FVIII:C
Time frame: Prior to the first infusion up to 72 hours postinfusion
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration of FVIII:C
AUC^0-T of VWF:RCo
Time frame: Prior to the first infusion up to 72 hours postinfusion
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration of VWF:RCo
AUC^0-T of VWF:Ag
Time frame: Prior to the first infusion up to 72 hours postinfusion
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration of VWF:Ag
AUC^0-T of VWF:CB
Time frame: Prior to the first infusion up to 72 hours postinfusion
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration of VWF:CB
in vivo recovery of FVIII:C
Time frame: Prior to the first infusion up to 72 hours postinfusion
in vivo recovery of VWF:RCo
Time frame: Prior to the first infusion up to 72 hours postinfusion
in vivo recovery of VWF:Ag
Time frame: Prior to the first infusion up to 72 hours postinfusion
in vivo recovery of VWF:CB
Time frame: Prior to the first infusion up to 72 hours postinfusion
Half-life of FVIII:C
Time frame: Prior to the first infusion up to 72 hours postinfusion
Terminal elimination half-life
Half-life of VWF:RCo
Time frame: Prior to the first infusion up to 72 hours postinfusion
Terminal elimination half-life
Half-life of VWF:Ag
Time frame: Prior to the first infusion up to 72 hours postinfusion
Terminal elimination half-life
C^max of FVIII:C
Time frame: Prior to the first infusion up to 72 hours postinfusion
Maximum observed plasma and/or serum concentration of FVIII:C
C^max of VWF:RCo
Time frame: Prior to the first infusion up to 72 hours postinfusion
Maximum observed plasma and/or serum concentration of VWF:RCo
C^max of VWF:Ag
Time frame: Prior to the first infusion up to 72 hours postinfusion
Maximum observed plasma and/or serum concentration of VWF:Ag
C^max of VWF:CB
Time frame: Prior to the first infusion up to 72 hours postinfusion
Maximum observed plasma and/or serum concentration of VWF:CB
T^max of FVIII:C
Time frame: Prior to the first infusion up to 72 hours postinfusion
Time of maximum observed plasma and/or serum concentration of FVIII:C
T^max of VWF:RCo
Time frame: Prior to the first infusion up to 72 hours postinfusion
Time of maximum observed plasma and/or serum concentration of VWF:RCo
T^max of VWF:Ag
Time frame: Prior to the first infusion up to 72 hours postinfusion
Time of maximum observed plasma and/or serum concentration of VWF:Ag
T^max of VWF:CB
Time frame: Prior to the first infusion up to 72 hours postinfusion
Time of maximum observed plasma and/or serum concentration of VWF:CB
Mean residence time of FVIII:C
Time frame: Prior to the first infusion up to 72 hours postinfusion
Average amount of time that a single molecule of drug stays in the body.
Mean residence time of VWF:RCo
Time frame: Prior to the first infusion up to 72 hours postinfusion
Average amount of time that a single molecule of drug stays in the body of VWF:RCo
Mean residence time of VWF:Ag
Time frame: Prior to the first infusion up to 72 hours postinfusion
Average amount of time that a single molecule of drug stays in the body of VWF:Ag
Mean residence time of VWF:CB
Time frame: Prior to the first infusion up to 72 hours postinfusion
Average amount of time that a single molecule of drug stays in the body of VWF:CB
Clearance of FVIII:C
Time frame: Prior to the first infusion, 30 minutes postinfusion, 10 hours postinfusion, and at 24, 48, and 72 hours postinfusion
Total plasma and/or serum clearance
Clearance of VWF:RCo
Time frame: Prior to the first infusion, 30 minutes postinfusion, 10 hours postinfusion, and at 24, 48, and 72 hours postinfusion
Total plasma and/or serum clearance
Clearance of VWF:Ag
Time frame: Prior to the first infusion, 30 minutes postinfusion, 10 hours postinfusion, and at 24, 48, and 72 hours postinfusion
Total plasma and/or serum clearance
Clearance of VWF:CB
Time frame: Prior to the first infusion, 30 minutes postinfusion, 10 hours postinfusion, and at 24, 48, and 72 hours postinfusion
Total plasma and/or serum clearance
Elimination rate constant of FVIII:C
Time frame: Prior to the first infusion up to 72 hours postinfusion
Elimination rate constant of VWF:RCo
Time frame: Prior to the first infusion up to 72 hours postinfusion
Elimination rate constant of VWF:Ag
Time frame: Prior to the first infusion up to 72 hours postinfusion
Elimination rate constant of VWF:CB
Time frame: Prior to the first infusion up to 72 hours postinfusion
Volume of distribution of FVIII:C
Time frame: Prior to the first infusion up to 72 hours postinfusion
Volume of distribution of VWF:RCo
Time frame: Prior to the first infusion up to 72 hours postinfusion
Volume of distribution of VWF:Ag
Time frame: Prior to the first infusion up to 72 hours postinfusion
Volume of distribution of VWF:CB
Time frame: Prior to the first infusion up to 72 hours postinfusion
VWF multimeric pattern
Time frame: Prior to the first infusion up to 12 hours postinfusion
For type 3 VWD subjects
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided
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Von Willebrand Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing plasma-derived FVIII/VWF concentrate in people with Von Willebrand Disease, run by Grifols Therapeutics LLC at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC^0-inf of coagulation factor VIII activity (FVIII:C) (time frame: Prior to the first infusion up to 72 hours postinfusion). The study lists 40 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.