VEYVONDI 1300I IU powder and solvent for solution for injection ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
288Autoimmune acquired coagulation factor deficiency1

288. Autoimmune acquired coagulation factor deficiency


Clinical trials : 205 Drugs : 238 - (DrugBank : 31) / Drug target genes : 18 - Drug target pathways : 26
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-001477-33-BE
(EUCTR)
27/02/201729/11/2016A study to determine the effectiveness, safety, and tolerability of the Recombinant Von Willebrand Factor administered with or without Advate for children diagnosed with Severe von Willebrand Disease who experience bleeding episodes and/or will undergo major, minor or oral surgery procedures.A Phase 3, Prospective, Multicenter, Uncontrolled, Open-Label Clinical Study to Determine the Efficacy, Safety, and Tolerability of rVWF with or without ADVATE in the Treatment and Control of Bleeding Episodes, the Efficacy and Safety of rVWF in Elective and Emergency Surgeries, and the Pharmacokinetics (PK) of rVWF in Children Diagnosed with Severe von Willebrand Disease.PIP decision numbers P/0091/2012, P/0214/2015, P/0394/2019 and P/0463/2020 - BAX 111 rVWF in Pediatrics Hereditary severe von Willebrand Disease in children
MedDRA version: 20.0;Level: LLT;Classification code 10055168;Term: Von Willebrand's factor deficiency;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: VEYONDI 650IU powder and solvent for solution for injection
Product Name: Recombinant von Willebrand Factor 650IU
Product Code: BAX111
INN or Proposed INN: Vonicog alfa
Other descriptive name: HUMAN VON WILLEBRAND FACTOR
Trade Name: ADVATE 500 IU powder and solvent for solution for injection
Product Name: Advate
INN or Proposed INN: OCTOCOG ALFA
Trade Name: VEYVONDI 1300I IU powder and solvent for solution for injection
Product Name: Recombinant von Willebrand Factor 1300IU
Product Code: BAX111
INN or Proposed INN: Vonicog alfa
Other descriptive name: HUMAN VON WILLEBRAND FACTOR
Trade Name: ADVATE 1000IU powder and solvent for solution for injection
Product Name: Advate
INN or Proposed INN: OCTOCOG ALFA
Baxalta Innovations GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
34Phase 3United States;Czechia;Finland;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Germany;Netherlands