A clinical trial to study the efficacy and safety of Human Factor VWF/VIII Concentrate (Wilateï¿½) in patients with Von Willebrand Disease (VWD) who undergo surgical procedures.

Prospective, Open-Label, Multi-Center, Phase III Clinical Study To Investigate The Efficacy And Safety Of Human Factor VWF/VIII Concentrate (Wilateï¿½) In Subjects With Inherited Von Willebrand Disease (VWD) Who Undergo Surgical Procedures - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/05/001771

Enrollment

Registered

2011-05-30

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Surgery in inherited Von Willebrand Disease

Interventions

Intervention1: Human Factor VWF/VIII Concentrate (Wilateï¿½): Route of Administration ï¿½ Intravenous Dosage ï¿½Major Surgery: Loading dose - Loading dose 40-60 VWF:RCo IU/kg or a peak plasma VWF:RCo

maintenance dose 20-40 VWF:RCoIU/kg every 12-24 hours or Â½ of the loading dose should be administered

trough levels of VWF:RCo should be maintained at greater than 30% for at least 2 days. Gastrointestinal Surgery: In the case of surgeries/ procedures of the GI tract, these may need increased dosing

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female subjects who are at least 6 years of age. 2. Diagnosed with congenital VWD (any type) where VWF:RCo is below 40% at screening or the subject has a diagnosis of Type 1, 2 or 3 VWD and a history of VWF:RCo below 40% documented in their medical notes at enrolment. 3. Require therapy with a VWF product to treat any potential surgical procedure. 4. Negative for anti-human immunodeficiency virus (HIV); if positive, viral load less than 200 particles/microlitre or less than 400,000 copies/mL and CD4+ count greater than 200/microlitre. 5. The subject and/or legally acceptable representative understands the nature of the study, gives written informed consent to participate in the study and is willing and able to comply with the protocol.

Exclusion criteria

Exclusion criteria: 1. Known coagulation disorder other than congenital VWD 2. Any VWF containing product administered within 3 days prior to the screening visit. 3. Any subject where it is planned to infuse the investigational product via continuous infusion. 4. Have a known history of, or are suspected to have VWF or FVIII inhibitors. 5. Emergency surgery or any surgery with a degree of urgency not permitting completion of baseline assessment required by the study protocol. 6. Suffering an acute or chronic medical condition, other than VWD, which may in the opinion of the Investigator affect the conduct of the study. 7. Subjects with active hepatic disease (ALT or AST levels gretare than 5 times the upper limit of normal) 8. Have a known or suspected hypersensitivity or previous evidence of severe side effects to Wilateï¿½ or other VWF/FVIII concentrates. 9. Subjects receiving immune-modulating drugs (other than anti-retroviral chemotherapy) such as alpha-interferon, prednisone (equivalent to 10 mg/day), or similar drugs at study start. 10. Pregnant women within the first 20 weeks of gestation. 11. Subjects having evidence or a history (within the previous 12 months) of abuse of any drug substance, licit or illicit. 12. Participation in another interventional clinical study currently or during the past 4 weeks.

Design outcomes

Primary

Measure	Time frame
Overall hemostatic efficacy (success or failure) of Wilateï¿½ in the treatment of VWD subjects who undergo a surgical procedure.Outcome Name: Overall hemostatic efficacy (success or failure) of Wilateï¿½ in the treatment of VWD subjects who undergo a surgical procedure.Timepoint: 6 days from surgery or after the last infusion as per the patients requirement.	—

Secondary

Measure	Time frame
Assessment of intra-operative and post-operative hemostatic efficacy according to 4 point ordinal efficacy scales.Timepoint: shortly after surgery and within 24 hours after last maintenance dose;Assessment of the in vivo recovery (IVR) of VWF:RCo, VWF:Ag and FVIII:C.Timepoint: At screening visit;Documentation of actual dosage and duration of treatment during surgical procedures.Timepoint: At screening, prior to surgery, during surgery, and for all maintenance doses;Measurement of VWF:RCo and FVIII:C plasma activity during treatment.Timepoint: At screening, prior to surgery, during surgery, and for all maintenance doses;The nature and incidence of adverse events (AEs)Timepoint: Daily from screening date through completion visit	—

Measure

Time frame

Assessment of intra-operative and post-operative hemostatic efficacy according to 4 point ordinal efficacy scales.Timepoint: shortly after surgery and within 24 hours after last maintenance dose;Assessment of the in vivo recovery (IVR) of VWF:RCo, VWF:Ag and FVIII:C.Timepoint: At screening visit;Documentation of actual dosage and duration of treatment during surgical procedures.Timepoint: At screening, prior to surgery, during surgery, and for all maintenance doses;Measurement of VWF:RCo and FVIII:C plasma activity during treatment.Timepoint: At screening, prior to surgery, during surgery, and for all maintenance doses;The nature and incidence of adverse events (AEs)Timepoint: Daily from screening date through completion visit

—

Countries

Bulgaria, India, Italy, Oman, Poland, Romania, South Africa, Turkey, United States of America

Contacts

Public ContactDrShariq Anwar

Medical Monitor, Max Neeman International

Sumbul.Siddiqui@neemanasia.com91-8130666357

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026