Advate®

DRUG3 trials

Sponsors

Novo Nordisk A/S, Bioverativ Therapeutics Inc., Runhui WU

Conditions

Congenital Bleeding DisorderHaemophilia AHemophilia a with InhibitorSevere Hemophilia A

Phase 1

Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects

CompletedNCT00837356

Novo Nordisk A/SCongenital Bleeding Disorder, Haemophilia A

Start: 2009-03-31End: 2009-10-31Updated: 2017-02-10

Phase 3

Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Subjects With Severe Hemophilia A

CompletedNCT01181128

Bioverativ Therapeutics Inc.Severe Hemophilia A

Start: 2010-11-30End: 2012-08-31Updated: 2021-01-08

Phase 4

Assessing Different FVIII Doses and Frequencies in Immune Tolerance Induction (ITI) with ADVATE Among Hemophilia a Boys with Inhibitor (INITIATE Study)

RecruitingNCT06864975

Runhui WUHemophilia a with Inhibitor

Start: 2025-03-01End: 2028-06-21Target: 110Updated: 2025-03-07

Related Papers

Long-term efmoroctocog alfa prophylaxis improves perceived pain, mental, and physical health in patients with hemophilia A: <i>post hoc</i> analysis of phase III trials using patient-reported outcomes.

2024-07-30

A post hoc analysis of previously untreated patients with severe hemophilia A who developed inhibitors in the PUPs A-LONG trial

Blood Advances2024-01-241 citations

First study of extended half-life rFVIIIFc in previously untreated patients with hemophilia A: PUPs A-LONG final results

Blood2022-04-1429 citations

Clinical studies of extended-half-life recombinant FVIII products for prophylaxis in adults and children: A critical review from the physician's perspective.

2022-04-0413 citations

Improvement in pain-related quality of life in patients with hemophilia A treated with rFVIIIFc individualized prophylaxis: post hoc analysis from the A-LONG study

Therapeutic Advances in Hematology2022-01-0111 citations

Population Pharmacokinetic Analysis of Recombinant Factor VIII Fc Fusion Protein in Subjects With Severe Hemophilia A: Expanded to Include Pediatric Subjects

The Journal of Clinical Pharmacology2021-03-152 citations

Recombinant factor VIII Fc fusion protein for the treatment of severe haemophilia A: Final results from the ASPIRE extension study

Haemophilia2020-03-3072 citations

Design of a prospective observational study on the effectiveness and real-world usage of recombinant factor VIII Fc (rFVIIIFc) compared with conventional products in haemophilia A: the A-SURE study

BMJ Open2019-05-0110 citations

ASPIRE Final Results Confirm Established Safety and Sustained Efficacy for Up to 4 Years of Treatment With rFVIIIFc in Previously Treated Subjects With Severe Hemophilia A

Blood2018-11-295 citations

Long-Term Efficacy and Quality of Life with Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) Prophylaxis in Pediatric, Adolescent, and Adult Subjects with Target Joints and Severe Hemophilia a

Blood2016-12-025 citations

Longitudinal Analysis of Long-Term Safety and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIFc) in Adults/Adolescents with Severe Hemophilia a

Blood2016-12-02