Evaluation of a Recombinant Factor IX Product, APVO101, in Previously-Treated Pediatric Patients With Hemophilia B

PHASE3CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

January 16, 2020

Primary Completion Date

July 4, 2022

Study Completion Date

July 4, 2022

Conditions
Hemophilia B
Interventions
DRUG

APVO101

Subjects will receive a single IV dose of APVO101 twice weekly or at a frequency of infusions as determined appropriate by the investigator for the particular study subject for a total of 50 ED. The starting prophylaxis dose will be based on APVO101 recovery from PK Phase assessments (only pre-infusion and 15-30 minute post-infusion samples).

Trial Locations (11)

1500

Worthwhile Clinical Trials, Lakeview Hospital, Benoni

2193

Haemophilia Comprehensive Care Centre, Johannesburg

35100

Ege University School ofMedicine, Izmir

79044

State Institute: Institute of Blood Pathology and Transfusion Medicine of the National Academy of Medical Sciences of Ukraine, Lviv

29040-090

Centro Estadual de Hemopterapia e Hematologia do Espirito Santo, Vitória

13083-878

Universidade Estadual de Campinas - Centro de Hematologia e Hemoterapia, Campinas

14051-140

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo, Ribeirão Preto

0159

JSC K Eristavi National Center for Experimental and Clinical Surgery, Tbilisi

MD-2062

PMSI Institute of Mother and Child, Chisinau

01330

Cukurova University School of Medicine, Adana

01135

National Specialized Children's Hospital OKHMATDYT, Kyiv

Sponsors
All Listed Sponsors
lead

Medexus Pharma, Inc.

INDUSTRY