Study of Voncento® in Subjects With Von Willebrand Disease
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02552576 |
Recruitment Status :
Completed
First Posted : September 17, 2015
Last Update Posted : May 16, 2018
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Condition or disease | Intervention/treatment | Phase |
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Von Willebrand Disease | Biological: Voncento | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects With Von Willebrand Disease |
Actual Study Start Date : | October 5, 2015 |
Actual Primary Completion Date : | February 15, 2018 |
Actual Study Completion Date : | February 15, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Voncento
The frequency and dose of Voncento administration will be determined by the investigator using the information included in the Voncento Summary of product characteristics (SmPC)
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Biological: Voncento
Human coagulation VWF / coagulation factor VIII (FVIII) complex concentrate |
- Haemostatic efficacy - NSB event [ Time Frame: Assessed daily by the subject until the bleed stops, for the duration of the subject's participation in the study (approximately 12 months). Each bleeding event is also to be assessed retrospectively by the Investigator. ]Subject's and investigator's assessment of haemostatic efficacy of Voncento in its usage for a non-surgical bleeding (NSB) event. Assessments of haemostatic efficacy will be based on a 4-point ordinal scale of Excellent, Good, Moderate or None.
- Number of infusions - NSB event [ Time Frame: For the duration of the subject's participation in the study (approximately 12 months). ]Number of infusions of Voncento required to treat an NSB event.
- Total dose of Voncento - NSB event [ Time Frame: For the duration of the subject's participation in the study (approximately 12 months). ]Total dose of Voncento (in international units of Von Willebrand Factor: Ristocetin Cofactor) required to treat an NSB event.
- Number of NSB events per month [ Time Frame: From Day 1 until final study visit, approximately 12 months. ]
- Annual bleeding rate [ Time Frame: For the duration of the subject's participation in the study (approximately 12 months). ]The number of bleeding events per year
- Assessment of blood loss during a surgical procedure [ Time Frame: During surgery, for any surgical procedure during the subject's participation in the study (approximately 12 months). ]
- Haemostatic efficacy - surgical event [ Time Frame: Assessed during and after surgery until the bleeding stops, for any surgical procedure during the subject's participation in the study (approximately 12 months). ]Investigator's or surgeon's assessment of haemostatic efficacy of Voncento in its usage for a surgical bleeding event. Assessments of haemostatic efficacy will be based on a 4-point ordinal scale of Excellent, Good, Moderate or None.
- Number of infusions - surgical bleeding event [ Time Frame: For the duration of the subject's participation in the study (approximately 12 months). ]Number of infusions of Voncento required to treat a surgical bleeding event.
- Total dose of Voncento - surgical bleeding event [ Time Frame: For the duration of the subject's participation in the study (approximately 12 months). ]Total dose of Voncento (in international units of Von Willebrand Factor: Ristocetin Cofactor) required to treat a surgical bleeding event.
- Overall adverse events [ Time Frame: From Day 1 until the final study visit for each subject (approximately 12 months) ]Overall number of subjects with: adverse events (AEs), serious AEs, AEs related to Voncento administration, and adverse events of special interest.
- Number of subjects with VWF or FVIII inhibitors [ Time Frame: At screening, Day 1 and approximately Months 3, 6, 9 and 12, for each subject. ]
- Haemostatic efficacy - prophylaxis [ Time Frame: Approximately every month (subject assessment) and every 3 months (Investigator assessment) for the duration of the subject's participation in the study (approximately 12 months). ]Subject's and investigator's assessment of haemostatic efficacy of Voncento as prophylaxis therapy. Assessments of haemostatic efficacy will be based on a grading scale with outcomes of excellent, good, moderate, none.

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of severe type 1, 2A, or 3 VWD where Von Willebrand Factor: Ristocetin Cofactor (VWF:RCo) is <20% at screening
- Desmopressin acetate treatment is ineffective, contraindicated, or not available for subject (type 3 VWD subjects only).
- Evidence of vaccination against hepatitis A and B or presence of antibodies against hepatitis A and B due to either a previous infection or prior immunization.
- Written informed consent given.
- Require a VWF product to control a non-surgical bleeding (NSB) event or for ongoing prophylactic therapy.
Exclusion Criteria:
- Known history or suspicion of having VWF or FVIII inhibitors
- Acute or chronic medical condition, other than VWD, which may affect the conduct of the study
- Known or suspected hypersensitivity or previous evidence of severe side effects to Voncento, VWF / FVIII concentrates, or human albumin.
- Participated in another interventional clinical study within 30 days before the first administration of Voncento or at any time during the study.
- Females who are pregnant, breast-feeding or who have a positive pregnancy test at screening
- Alcohol, drug, or medication abuse within 1 year before the study.
- Currently receiving a therapy not permitted during the study.
- Previous participation in a Voncento / Biostate study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02552576
Austria | |
Study Site | |
Vienna, Austria | |
Germany | |
Study Site | |
Duisburg, Germany | |
Study Site | |
Frankfurt, Germany | |
Greece | |
Study Site | |
Athens, Greece | |
Poland | |
Study Site | |
Krakow, Poland | |
Study Site | |
Rzeszów, Poland | |
Study Site | |
Wroclaw, Poland | |
United Kingdom | |
Study Site 14 | |
London, United Kingdom | |
Study Site 40 | |
London, United Kingdom | |
Study Site 42 | |
London, United Kingdom | |
Study Site 47 | |
London, United Kingdom | |
Study Site 8 | |
London, United Kingdom |
Study Director: | Study Director | CSL Behring |
Responsible Party: | CSL Behring |
ClinicalTrials.gov Identifier: | NCT02552576 |
Other Study ID Numbers: |
CSLCT-BIO-12-83 2013-003305-25 ( EudraCT Number ) |
First Posted: | September 17, 2015 Key Record Dates |
Last Update Posted: | May 16, 2018 |
Last Verified: | May 2018 |
Von Willebrand Diseases Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases |
Coagulation Protein Disorders Blood Platelet Disorders Hemorrhagic Disorders Genetic Diseases, Inborn |