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Coagulation Factor

Wilate for Von Willebrand Disease

Phase 3

Waitlist Available

Research Sponsored by Octapharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Type 3 (at least four patients), severe type 2 (except 2N) or severe type 1 VWD (any of which with VWF:RCo <20%) according to medical history, requiring substitution therapy with a VWF-containing product

Minimum body weight 12.5 kg at the time of screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and at 1, 2, 3, 6, 9, and 12 months of treatment

Awards & highlights

Study Summary

This trial is testing a new medication to see if it is safe and effective in treating von Willebrand Disease in children under the age of 6.

Who is the study for?

This trial is for children under 6 with severe Von Willebrand Disease (VWF:RCo <20%) and a minimum body weight of 12.5 kg. They must not have had thromboembolic events, other bleeding disorders, or be on immunosuppressants like high-dose prednisone. Children can't join if they've used certain drugs recently or are allergic to the study drug's components.Check my eligibility

What is being tested?

The trial tests 'wilate' in young patients with severe VWD as routine prevention over one year. It aims to assess how effective it is, how the body processes it, whether it causes immune reactions, and its safety profile.See study design

What are the potential side effects?

While specific side effects for wilate aren't listed here, treatments for VWD typically may include reactions at injection sites, headaches, dizziness, allergic reactions or rashes. Close monitoring will identify any potential side effects during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a severe type of Von Willebrand Disease and need treatment with a specific product.

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I weigh at least 12.5 kg.

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I am under 6 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and at 1, 2, 3, 6, 9, and 12 months of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and at 1, 2, 3, 6, 9, and 12 months of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and at 1, 2, 3, 6, 9, and 12 months of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Total annualised bleeding rate (tABR) during prophylactic treatment with wilate.

Secondary outcome measures

AUC normalised for the administered dose (AUCnorm) of wilate for VWF:Ac (VWF:RCo) and FVIII:C (OS) over time

Area under the curve (AUC) of wilate for VWF:Ac (VWF:RCo) and FVIII:C (OS) over time

Clearance (CL) of wilate for VWF:Ac (VWF:RCo) and FVIII:C (OS) over time

+13 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: wilate treatmentExperimental Treatment1 Intervention

PK: Single dose of 80 IU/kg body weight (BW). Prophylactic treatment: 30-50 IU/kg BW administered 2-3 times per week at the recommended dose of over 12 months. Minor haemorrhage: loading dose 30-50 IU/kg BW followed by a maintenance dose of 30-40 IU/kg BW every 12-24 hours to achieve von Willebrand factor activity (VWF:Ac) and FVIII:C trough levels of >30%. Major haemorrhage: loading dose 50-80 IU/kg BW followed by a maintenance dose of 30-50 IU/kg BW every 12-24 hours to achieve VWF:Ac and FVIII:C trough levels of >50%. Minor surgery: loading dose of 40-60 IU/kg BW followed by a maintenance dose of 20-30 IU/kg BW every 12- 24 hours for up to 3 days, to achieve VWF:Ac peak levels of 50% after loading dose and trough levels >30% during maintenance. Major surgery: loading dose of 60-80 IU/kg BW followed by a maintenance dose of 30-40 IU/kg BW every 12-24 hours for up to 6 days or longer, to achieve VWF:Ac peak levels of 100% after loading dose and trough levels >50% during maintenance

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

OctapharmaLead Sponsor

84 Previous Clinical Trials

7,846 Total Patients Enrolled

Media Library

Wilate (Coagulation Factor) Clinical Trial Eligibility Overview. Trial Name: NCT04953884 — Phase 3

Von Willebrand Disease Research Study Groups: wilate treatment

Von Willebrand Disease Clinical Trial 2023: Wilate Highlights & Side Effects. Trial Name: NCT04953884 — Phase 3

Wilate (Coagulation Factor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04953884 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please explain the potential risks associated with wilate?

"There is already some efficacy data from Phase 3 trials as well as multiple rounds of safety data, so our team at Power rates the safety of wilate as a 3."

Answered by AI

Are there any current vacancies for participants in this research project?

"The listing on clinicaltrials.gov does show that this trial is open for recruitment. This trial was posted on 28th July 2021 and was last updated on 14th October 2022. The team conducting this trial needs 12 more patients from 1 more location."

Answered by AI

What other similar research has been conducted in the past?

"There have been a total of 8 clinical trials for wilate over the course of 4 years. These trials have taken place in 53 cities and 18 countries. The first study was sponsored by Baxalta and completed in 2017. 34 participants were involved in this Phase 3 drug approval stage."

Answered by AI

Is wilate a common ingredient in other medications?

"Currently, 8 clinical trials are investigating the efficacy of wilate with 6 of those in Phase 3. Several of the clinical trials are situated in Pittsburgh, Pennsylvania; however, 125 locations total are running studies."

Answered by AI

What is the standard use of wilate?

"While typically used to treat hemophilia, wilate can also be given to patients with von willebrand disease to prevent them from losing too much blood during and after surgery."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy, PK, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease VWD) Patients <6 Years of Age

2021. "Efficacy, PK, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease VWD) Patients <6 Years of Age". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04953884.

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