NCT00951405

Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With Inhibitors

Completed Phase 2 Last updated 5 September 2018

What this trial tests

Phase 2 trial testing activated recombinant human factor VII, long acting in Congenital Bleeding Disorder in 23 participants. Completed in 29 March 2011.

Timeline

1 September 2009

Primary endpoint
29 March 2011

29 March 2011

Quick facts

Lead sponsor	Novo Nordisk A/S
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	23
Start date	1 September 2009
Primary completion	29 March 2011
Estimated completion	29 March 2011
Sites	25 locations across France, South Africa, Japan, Malaysia, Serbia and Montenegro, Serbia, Sweden, United Kingdom

Drugs / interventions tested

• activated recombinant human factor VII, long acting — full drug profile →
• activated recombinant human factor VII, long acting — full drug profile →
• activated recombinant human factor VII, long acting — full drug profile →

Conditions studied

• Congenital Bleeding Disorder — all drugs for Congenital Bleeding Disorder →
• Haemophilia A With Inhibitors — all drugs for Haemophilia A With Inhibitors →
• Haemophilia B With Inhibitors — all drugs for Haemophilia B With Inhibitors →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

Adults 12 to 65, male only, with Congenital Bleeding Disorder or Haemophilia A With Inhibitors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial is conducted in Asia, Europe, Japan and North America. The aim of this clinical trial is to investigate the safety and the efficacy of a prophylactic treatment option with long acting coagulation factor VII (LA-rFVIIa) for haemophilia patients with inhibitors.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 40K glycoPEGylated, recombinant FVIIa: 3-month, double-blind, randomized trial of safety, pharmacokinetics and preliminary efficacy in hemophilia patients with inhibitors.
   Ljung R, Karim FA, Saxena K, Suzuki T, et al · · 2013 · cited 25× · PMID 23578227 · DOI 10.1111/jth.12237
2. New treatments in hemophilia: insights for the clinician.
   Knobe K, Berntorp E. · · 2012 · cited 13× · PMID 23556123 · DOI 10.1177/2040620712440007