Haemophilia A MedDRA version: 20.0 Level: LLT Classification code 10060612 Term: Hemophilia A System Organ Class: 100000011915
Conditions
Interventions
Trade Name: Voncento
Product Name: Voncento
Pharmaceutical Form: Powder and solution for solution for injection
INN or Proposed INN: Human Coagulation Factor VIII
Other descriptive name: HUMAN COAGULA
Sponsors
CSL Behring GmbH
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Subjects meeting all of the following inclusion criteria may be enrolled into the study: 1. Capable of providing written informed consent and willing and able to adhere to all protocol requirements and / or the subject’s parent(s) or legally acceptable representative(s) capable of providing written informed consent. 2. Male subjects of any age. 3. Diagnosis of haemophilia A with plasma FVIII levels =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following exclusion criteria must not be enrolled into the study: 1. Participated in another clinical study with a plasma-derived or recombinant FVIII product other than Voncento® / Biostate® / Aleviate® / TBSF High Purity FVIII Concentrate within 30 days before the first administration of Voncento or at any time during the study. 2. Known history of FVIII inhibitors or suspicion of having FVIII inhibitors (however subjects who have completed successful ITI treatment and have had documented FVIII inhibitor level <0.6 BU for at least 3 years following ITI may be included) . 3. Currently receiving a therapy not permitted during the study (as defined in Section 9.3.1.4), which cannot be discontinued prior to enrolment into the study. 4. Previous participation in the current study. 5. Mental condition rendering the subject (or the subject’s legally acceptable representative[s]) unable to understand the nature, scope, and possible consequences of the study. 6. Known or suspected hypersensitivity to Voncento, or to any excipients of Voncento. 7. Any issue that, in the opinion of the investigator, would render the subject unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the immunogenicity of Voncento in Previously Treated Patients (PTPs) with haemophilia A. ;Secondary Objective: To investigate the long-term safety of Voncento in previously treated patients with haemophilia A.;Primary end point(s): The primary study endpoint is the incidence of FVIII inhibitor development.;Timepoint(s) of evaluation of this end point: The presence of FVIII inhibitors will be assessed by a central laboratory at every scheduled site visit (Visit 1-4), and additionally as required to assess any case of suspected inhibitors. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints of the study are based on the AEs and AESIs reported: • Nature and incidence of reported AEs, including SAEs. • (S)AEs related to Voncento treatment. • AESIs: thromboembolic events, hypersensitivity reactions, and suspected transmission of infectious agents. • Lack of effect (ie, a less than expected response to Voncento treatment when given for a bleeding event) as assessed by the investigator.;Timepoint(s) of evaluation of this end point: AEs after signing the informed consent form with a start date on or after the first dose of Voncento will be collected. AEs will be assessed at every scheduled site visit (Visit 2-4). | — |
Countries
Germany, Hong Kong, Malaysia
Contacts
Public ContactKerstin Jung,Clinical Study Manager
CSL Behring GmbH
Outcome results
None listed