| CTRI Number |
CTRI/2011/05/001771 [Registered on: 30/05/2011] Trial Registered Prospectively |
| Last Modified On: |
18/06/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
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. |
Scientific Title of Study
Modification(s)
|
Prospective, Open-Label, Multi-Center, Phase III Clinical Study To Investigate The Efficacy And Safety Of Human Factor VWF/VIII Concentrate (Wilate�) In Subjects With Inherited Von Willebrand Disease (VWD) Who Undergo Surgical Procedures |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2010-021162-30 |
EudraCT |
| Wil-24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Alok Srivastava |
| Designation |
Head-Department of Haematology |
| Affiliation |
Christian Medical College,Vellore, |
| Address |
Dr. Alok Srivastava
Head-Department of Haematology
Christian Medical College,Vellore, Tamil Nadu-632004
Vellore
TAMIL NADU
632004
India |
| Phone |
0416-2282892 |
| Fax |
0416-2282035 |
| Email |
aloks@cmcvellore.ac.in |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Sumbul Siddiqui |
| Designation |
Medical Monitor |
| Affiliation |
Medical Monitor, Max Neeman International |
| Address |
Max Neeman International
Max House, 1, Dr Jha Marg, Okhla Phase III, New Delhi- 110020
New Delhi
DELHI
110020
India |
| Phone |
91-8130666357 |
| Fax |
011-41001945 |
| Email |
Sumbul.Siddiqui@neemanasia.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
DrShariq Anwar |
| Designation |
Director Operations |
| Affiliation |
Max Neeman International |
| Address |
Max Neeman International, Max House, 1st Floor, 1, Dr. Jha Marg, Okhla Phase III,New Delhi-110020
Max House, 1st Floor, 1, Dr. Jha Marg, Okhla Phase III
New Delhi
DELHI
110020
India |
| Phone |
011-40772100 |
| Fax |
011-40548168 |
| Email |
Shariq.Anwar@neemanasia.com |
|
|
Source of Monetary or Material Support
|
| Octapharma AG
Seidenstrasse 2
8853 Lachen
Switzerland
|
|
|
Primary Sponsor
|
| Name |
Octapharma AG |
| Address |
Seidenstrasse 2 8853 Lachen Switzerland |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Max Neeman Medical International Limited |
Max House, 1, Dr. Jha Marg Okhla Phase III New Delhi-110020 |
|
Countries of Recruitment
Modification(s)
|
India
Italy
Poland
Turkey
United States of America
Bulgaria
Oman
Romania
South Africa |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Alok Srivastava |
Christian Medical College |
Department of Haematology,Christian Medical College-632004
Vellore
TAMIL NADU |
0416 2282892
0416 2282035
aloks@cmcvellore.ac.in |
| Dr. Shashikant Janardan Apte |
Sahyadri Speciality Hospital |
Sahyadri Speciality Hospital, ,30C , Erandawane , Karve Road,Pune-411 004-
Pune
MAHARASHTRA |
+91 9822404983
shashikant.apte@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Review Board,Christian Medical College Vellore |
Approved |
| Sahyadri Hospitals Limited Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Surgery in inherited Von Willebrand Disease, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Human Factor VWF/VIII Concentrate (Wilate�) |
Route of Administration � Intravenous Dosage �Major Surgery: Loading dose - Loading dose 40-60 VWF:RCo IU/kg or a peak plasma VWF:RCo level of 100% maintenance dose - 20-40 VWF:RCo IU/kg every 12-24 hours or � of the loading dose (These dosage recommendations can be adjusted using the results of the baseline recovery study) Dosage Regimen - Trough levels of VWF:RCo should be maintained at greater than or equal to 50% for at least 6 days. Further doses can be given if required by the patient.
Minor Surgery: Loading dose of 30 to 60 VWF:RCo IU/kg should be given within 3 hours of start of the surgeical procedure to achieve peak plasma VWF:RCo level of 50%; maintenance dose 20-40 VWF:RCoIU/kg every 12-24 hours or ½ 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 and shorter intervals of treatment. If these procedures are included in the study population, the treatment will be individualized according to the severity of bleeding and history of the patient by the treating physician. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
Inclusion Criteria
Modification(s)
|
| Age From |
6.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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 Wilate� 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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| 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
Modification(s)
|
| Outcome |
TimePoints |
| 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 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="41"
Sample Size from India="13"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
17/09/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
06/06/2011 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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 |