Indiana Hemophilia and Thrombosis Center | Indianapolis, IN
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
The main aim of the study is to check effectiveness of rVWF (vonicog alfa) prophylaxis based on the annualized bleeding rate (ABR) of spontaneous (not related to trauma) bleeding episodes in pediatric and adult participants during the first 12 months on study treatment.
The participants will be treated with rVWF for a maximum of 3 years. Their von Willebrand Disease will be treated according to Investigational product (IP) dosing directions.
Enrollment
Sex
Volunteers
Inclusion criteria
The participant will not be considered eligible for the study without meeting all of the criteria below.
Participants who have completed Study 071301 or Study 071102 (or participants who have completed the surgery arm treatment in Study 071102 and want to continue to receive on-demand (OD) treatment) and are willing to immediately transition into this study, must meet the following 2 criteria to be eligible for this study:
New participants (Cohort 4) who meet the above 2 and ALL the following additional criteria are eligible for this study:
Diagnosis is confirmed by genetic testing and multimer analysis, documented in participant history or at screening.
Exclusion criteria
The participant will be excluded from the study if any of the following exclusion criteria are met.
Delay criteria Only for Cohort 4, if the participant presents with an acute bleeding episodes or acute illness (eg, influenza, flu-like syndrome, allergic rhinitis/conjunctivitis, and non-seasonal asthma) the screening visit will be postponed until the participant has recovered. For all other participants, end of study (EOS) visit for 071102 or 071301 will be completed per protocol and the completed EOS in Study 071102 or 071301 will also serve as the screening visit for this continuation study (SHP677-304).
Primary purpose
Allocation
Interventional model
Masking
71 participants in 2 patient groups
Loading...
Central trial contact
Shire Contact
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal