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

Phase 3

Completed

• Conditions: Surgery in inherited Von Willebrand Disease

• Registration Number: CTRI/2011/05/001771
• Lead Sponsor: Octapharma AG

Brief Summary

This study is a prospective, open-label, multi-centre trial to investigate the efficacy and safety of Human Factor VWF/VIII Concentrate (Wilate�) in patients with congenital Von Willebrand Disease (VWD) who undergo surgical procedures. The trial will be conducted in India and 8 other countries, namely, USA, Italy, Poland, Oman, South Africa, Bulgaria, Romania and Turkey. The purpose of this study is to measure intra-operative and post-operative hemostatic efficacy of Wilate� according to 4-point ordinal efficacy scales. No. of Patients to be Recruited from India - 13 Date of Enrolment - June 2011

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-17
• Last Update Posted: 2015-06-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Male and female subjects who are at least 6 years of age.
• 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.
• Require therapy with a VWF product to treat any potential surgical procedure.
• 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.
• 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

• Known coagulation disorder other than congenital VWD 2.
• Any VWF containing product administered within 3 days prior to the screening visit.
• Any subject where it is planned to infuse the investigational product via continuous infusion.
• Have a known history of, or are suspected to have VWF or FVIII inhibitors.
• Emergency surgery or any surgery with a degree of urgency not permitting completion of baseline assessment required by the study protocol.
• Suffering an acute or chronic medical condition, other than VWD, which may in the opinion of the Investigator affect the conduct of the study.
• 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 Wilate� or other VWF/FVIII concentrates.
• 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.
• Pregnant women within the first 20 weeks of gestation.
• Subjects having evidence or a history (within the previous 12 months) of abuse of any drug substance, licit or illicit.
• Participation in another interventional clinical study currently or during the past 4 weeks.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall hemostatic efficacy (success or failure) of Wilate� in the treatment of VWD subjects who undergo a surgical procedure.Outcome Name: Overall hemostatic efficacy (success or failure) of Wilate� in the treatment of VWD subjects who undergo a surgical procedure.	6 days from surgery or after the last infusion as per the patients requirement.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Christian Medical College; 🇮🇳 Vellore, TAMIL NADU, India

Sahyadri Speciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Christian Medical College

🇮🇳Vellore, TAMIL NADU, India

Dr. Alok Srivastava

Principal investigator

aloks@cmcvellore.ac.in