Safety and Efficacy of N8 in Haemophilia A Subjects

Condition(s) targeted: Haemophilia A

Intervention: recombinant factor VIII (N8) (Drug); Blood drawn for laboratory testing (Procedure)

Phase: Phase 3

Status: Recruiting

Sponsored by: Novo Nordisk

Official(s) and/or principal investigator(s):
Mette B. Larsen, Study Director, Affiliation: Novo Nordisk
Birgitte Denlow, Study Director, Affiliation: Novo Nordisk

Overall contact:
Novo Nordisk Clinical Trial Call Center, Phone: 866-867-7178

This trial is conducted in Africa, Asia, Europe, Japan, Oceania, and North and South America.

The trial consists of a main trial and a sub-trial. The main trial investigates safety and efficacy of recombinant factor VIII (N8) in haemophilia A subjects, while the sub-trial investigates safety and efficacy of N8 in prevention and treatment of bleeding during surgical procedures.

Official title: A Multi-centre, Open-label, Non-controlled Trial on Safety and Efficacy of N8 in Prevention and Treatment of Bleeds in Previously Treated Subjects With Haemophilia A. Sub-trial: Safety and Efficacy of N8 in Prevention and Treatment of Bleeding During Surgical Procedures in Subjects With Haemophilia A

Study design: Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The incidence rate of N8 inhibitors

Secondary outcome: Frequency of adverse events and serious adverse events reported

Minimum age: 12 Years. Maximum age: 65 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Severe haemophilia A (FVIII level less than or equal to 1%)

- Treatment history of more than 150 exposure days with recombinant or plasma-derived

FVIII replacement products

- Subjects can have elective surgery when at least 5 subjects have been treated with N8

for a bleeding episode and 80% of these subjects have a response rated excellent or good

Exclusion Criteria:

- Presence of any bleeding disorder in addition to haemophilia A

- Inhibitor titer greater than or equal to 0. 6 Bethesda Units (BU) at screening and

past history of inhibitor

- Abnormal renal function tests

- Known hypersensitivity

Novo Nordisk Clinical Trial Call Center, Phone: 866-867-7178

Rio de Janeiro 20211-030, Brazil; Not yet recruiting

Zagreb 10 000, Croatia; Recruiting

København 2100, Denmark; Not yet recruiting

Giessen 35392, Germany; Recruiting

Tel-Hashomer 52621, Israel; Recruiting

Firenze 50134, Italy; Recruiting

Nagoya-shi 466 8560, Japan; Recruiting

Kuala Lumpur 50400, Malaysia; Not yet recruiting

Saint-Petersburg 191065, Russian Federation; Recruiting

Novi Sad 21000, Serbia; Recruiting

Madrid 28046, Spain; Recruiting

Zürich 8091, Switzerland; Recruiting

Taipei 100, Taiwan; Recruiting

Adana 01130, Turkey; Recruiting

Manchester M13 9WL, United Kingdom; Not yet recruiting

Novo Nordisk Clinical Trial Call Center, Long Beach, California 90806, United States; Not yet recruiting

Novo Nordisk Clinical Trial Call Center, Tampa, Florida 33607, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Atlanta, Georgia 30322, United States; Not yet recruiting

Novo Nordisk Clinical Trial Call Center, Augusta, Georgia 30912, United States; Not yet recruiting

Novo Nordisk Clinical Trial Call Center, Indianapolis, Indiana 46260, United States; Not yet recruiting

Novo Nordisk Clinical Trial Call Center, Iowa City, Iowa 52242, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Omaha, Nebraska 68198-2168, United States; Not yet recruiting

Novo Nordisk Clinical Trial Call Center, Newark, New Jersey 07102, United States; Not yet recruiting

Novo Nordisk Clinical Trial Call Center, Cincinnati, Ohio 45229, United States; Not yet recruiting

Novo Nordisk Clinical Trial Call Center, Dayton, Ohio 45404, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Portland, Oregon 97239, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Philadelphia, Pennsylvania 19134-1095, United States; Not yet recruiting

Novo Nordisk Clinical Trial Call Center, Providence, Rhode Island 02903, United States; Not yet recruiting

Novo Nordisk Clinical Trial Call Center, Memphis, Tennessee 38163, United States; Not yet recruiting

Novo Nordisk Clinical Trial Call Center, Nashville, Tennessee 37232-6869, United States; Not yet recruiting

Novo Nordisk Clinical Trial Call Center, Fort Worth, Texas 76104, United States; Not yet recruiting

Novo Nordisk Clinical Trial Call Center, Charlottesville, Virginia 22908, United States; Not yet recruiting

Novo Nordisk Clinical Trial Call Center, Spokane, Washington 99220-2555, United States; Not yet recruiting

Clinical Trials at Novo Nordisk

Starting date: April 2009
Last updated: September 8, 2010