Von Willebrand Disease Clinical Trial
Official title:
A Post-marketing Observational Study to Assess the Efficacy and Safety of the FVIII/VWF Complex (Human), Alphanate®, in Preventing Excessive Bleeding During Surgery in Subjects With Congenital Type 3 Von Willebrand Disease
Verified date | August 2023 |
Source | Grifols Biologicals, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To assess the efficacy of FVIII/VWF Complex (Human), Alphanate® as replacement therapy in preventing excessive bleeding in subjects with congenital Type 3 von Willebrand Disease (VWD) who undergo surgical procedures.
Status | Active, not recruiting |
Enrollment | 15 |
Est. completion date | March 2029 |
Est. primary completion date | December 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years and older |
Eligibility | Inclusion Criteria: 1. Male or female 7 years of age or older 2. The subject has been diagnosed of inherited VWD of Type 3 as determined by subject's medical records. 3. The subject needs a surgical procedure (at least 10 surgical procedures have to be considered as "Major" according to the criteria of the protocol). 4. The subject is expected to respond to exogenously administered FVIII/VWF according to Investigator's judgment. 5. The subject freely gives written informed consent. Patients who are not legally permitted to provide written consent must sign a form of assent for study participation, and written consent must be provided by a parent or legal guardian. Exclusion Criteria: 1. The subject has been diagnosed of acquired VWD. 2. The subject is known to have history of intolerance to any Alphanate® containing substance. 3. The subject is known to have history of anaphylactic reaction(s) to blood or blood components. 4. Liver function tests (AST, ALT, bilirubin) > 2.5 x upper limit of normal (ULN). 5. Renal function test (creatinine, BUN) > 1.5 x ULN. 6. The subject is known or suspected to have present or past inhibitor activity (antibodies) directed against FVIII or VWF. 7. The subject is known to abuse alcohol or illicit drug use within the past 12 months. 8. The subject is participating in another clinical study involving an investigational treatment, or participated within the past 4 weeks (except if the patient is participating in another Alphanate® study). Studies consisting of data and blood sampling collections on a regular or long-term basis are exempt from this exclusion. 9. The subject is unlikely to adhere to the protocol requirements of the study. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Grifols Biologicals, LLC |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assess the efficacy of FVIII/VWF Complex (Human), Alphanate® as replacement therapy in preventing excessive bleeding in subjects with congenital Type 3 von Willebrand Disease (VWD) who undergo surgical procedures (mostly major surgeries). | 30 days | ||
Secondary | To assess the Day 0 (surgery day) and Day 1 (post-surgery day) treatment outcomes of each surgical procedure, rated by the investigator using a 2-point verbal rating scale. | 1 Day | ||
Secondary | Assessment of Safety and Tolerability | 30 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT01651468 -
The Effect of the Nutraceutical "Hemofix" on the Coagulation System
|
N/A | |
Terminated |
NCT00178542 -
Change in Thrombin Generation Potential and Thromboelastography During the Menstrual Cycle
|
N/A | |
Completed |
NCT02552576 -
Study of Voncento® in Subjects With Von Willebrand Disease
|
Phase 4 | |
Recruiting |
NCT02869074 -
Molecular and Clinical Profile of Von Willebrand Disease in Spain
|
||
Completed |
NCT01602419 -
Surveillance of Safety and Efficacy of Wilate in Patients With Von Willebrand Disease
|
||
Completed |
NCT01224808 -
Extension Study of Biostate in Subjects With Von Willebrand Disease
|
Phase 3 | |
Withdrawn |
NCT00694785 -
A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of ARC1779 Injection in Patients With Von Willebrand Disease Type 2B
|
Phase 2 | |
Completed |
NCT00805051 -
Acquired Von Willebrand Syndrome in Severe Aortic Stenosis
|
N/A | |
Completed |
NCT00168090 -
Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD)
|
Phase 4 | |
Completed |
NCT02246881 -
A Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Haemophilia A.
|
Phase 3 | |
Completed |
NCT04657887 -
Registry of Patients With Von WilLEbrand Disease Treated With Voncento®
|
||
Withdrawn |
NCT00630448 -
Collection of Blood in Normal Subjects and Subjects With Von Willebrand Disease (VWD)
|
N/A | |
Terminated |
NCT00387192 -
A Study With OPTIVATE® in People With Von Willebrand Disease
|
Phase 3 | |
Completed |
NCT02973087 -
rVWF IN PROPHYLAXIS
|
Phase 3 | |
Completed |
NCT01410227 -
Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor (rVWF) in the Treatment of Bleeding Episodes in Von Willebrand Disease (VWD)
|
Phase 3 | |
Completed |
NCT01949220 -
Willebrand International Non-interventional Global Surveillance
|
||
Completed |
NCT01589848 -
Study on Von Willebrand Disease and Hemophilia in Cuenca, Ecuador
|
N/A | |
Completed |
NCT00941616 -
Study of a pd VWF/FVIII Concentrate, Biostate®, in Subjects With Von Willebrand Disease
|
Phase 2/Phase 3 | |
Completed |
NCT00557908 -
The Von Willebrand Disease (VWD) International Prophylaxis Study
|
N/A | |
Active, not recruiting |
NCT04953884 -
Efficacy, PK, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease VWD) Patients <6 Years of Age
|
Phase 3 |