Trial record 4 of 8 for:
Open Studies | "von Willebrand Diseases"
Efficacy of Alphanate FVIII/VWF Concentrate in Type 3 Von Willebrand Patients
This study is currently recruiting participants.
Verified March 2013 by Grifols Biologicals Inc.
Sponsor:
Grifols Biologicals Inc.
Information provided by (Responsible Party):
Grifols Biologicals Inc.
ClinicalTrials.gov Identifier:
NCT00555555
First received: November 7, 2007
Last updated: March 18, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Von Willebrand Disease |
Biological: Alphanate SD/HT |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Post-marketing Observation Study to Assess the Efficacy and Safety of the FVIII/VWF Complex (Human,) Alphanate(R), in Preventing Excessive Bleeding During Surgery in Subjects With Congenital Type 3 Von Willebrand Disease |
Resource links provided by NLM:
Further study details as provided by Grifols Biologicals Inc.:
Primary Outcome Measures:
- 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). [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- Assessment of Safety and Tolerability [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 15 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | March 2017 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: Alphanate SD/HT |
Biological: Alphanate SD/HT
A general guideline based on the product Full Prescribing Information is recommended with a maximum dose of 80 VWF:RCof IU/kg. The number of administrations before, during, and after the surgery procedure depends on the subject's clinical condition and the type of surgery itself. Single administrations or multiple doses may be appropriate. The dose of Alphanate® administered to each subject will be recorded as IU of VWF:RCof and also as IU of FVIII:C. The lot number for each vial of concentrate administered will also be recorded.
Other Name: Alphanate(R) Factor VIII/VWF concentrate (Human).
|
Detailed Description:
For the treatment of surgical procedures the intended dose of Alphanate® will be given as a single dose or as multiple doses over several days, depending on the clinical situation, and according to the Full Prescribing Information guideline and the investigator's judgment. For each treated event, the subject's treatment period will be finished when, in the opinion of the local Investigator, the participating subject would not benefit from further infusions of the study concentrate.
Eligibility| Ages Eligible for Study: | 7 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female 7 years of age or older
- The subject has been diagnosed of inherited VWD of Type 3 as determined by subject's medical records.
- The subject needs a surgical procedure (at least 10 surgical procedures have to be considered as "Major" according to the criteria of the protocol).
- The subject is expected to respond to exogenously administered FVIII/VWF according to Investigator's judgment.
- 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:
- The subject has been diagnosed of acquired VWD.
- The subject is known to have history of intolerance to any Alphanate® containing substance.
- The subject is known to have history of anaphylactic reaction(s) to blood or blood components.
- Liver function tests (AST, ALT, bilirubin) > 2.5 x upper limit of normal (ULN).
- Renal function test (creatinine, BUN) > 1.5 x ULN.
- The subject is known or suspected to have present or past inhibitor activity (antibodies) directed against FVIII or VWF.
- The subject is known to abuse alcohol or illicit drug use within the past 12 months.
- 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.
- The subject is unlikely to adhere to the protocol requirements of the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00555555
Contacts
| Contact: Paul J Pinciaro, PhD | 410-814-7617 | paul.pinciaro@grifols.com |
Locations
| United States, Ohio | |
| Cincinnati Children's Medical Center | Not yet recruiting |
| Cincinnati, Ohio, United States, 45229-3039 | |
| Contact: Ann Pillow 513-636-7198 anngreene.pillow@cchmc.org | |
| United States, Oklahoma | |
| Oklahoma Center for Bleeding and Clotting Disorders | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Sarah M Hawk, P.A. C 405-271-3661 ext 1 sarah-hawk@ouhsc.edu | |
Sponsors and Collaborators
Grifols Biologicals Inc.
Investigators
| Study Director: | Paul J Pinciaro, PhD | Grifols Biologicals Inc. |
More Information
No publications provided
| Responsible Party: | Grifols Biologicals Inc. |
| ClinicalTrials.gov Identifier: | NCT00555555 History of Changes |
| Other Study ID Numbers: | GBI 07-03 |
| Study First Received: | November 7, 2007 |
| Last Updated: | March 18, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Grifols Biologicals Inc.:
|
Factor VIII deficiency Von Willebrand disease FVIII/VWF concentrate Bleeding disorders Blood disorders |
Additional relevant MeSH terms:
|
Von Willebrand Diseases Von Willebrand Disease, Type 3 Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases Coagulation Protein Disorders Blood Platelet Disorders |
Hemorrhagic Disorders Genetic Diseases, Inborn Factor VIII Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013