Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B

PHASE3CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

July 2, 2014

Primary Completion Date

October 27, 2022

Study Completion Date

October 27, 2022

Conditions
Congenital Bleeding DisorderHaemophilia B
Interventions
DRUG

nonacog beta pegol

For intravenous (i.v.) injection. A single dose of 40 U/kg, unless the bleeding episode is severe in which case it should be treated with 80 U/kg.

Trial Locations (31)

100

National Taiwan University Children's Hospital, Taipei

500

Changhua Christian Hospital, Changhua

807

Kaohsiung Medical University Chung-Ho Memorial Hospital_Dept of Pediatrics, Kaohsiung City

3052

Royal Children's Hospital, Parkville

5020

LKH Salzburg- Univ. Klinik f. Kinder- und Jugendheilkunde, Salzburg

10400

RAMA-Dept of Paediatrics, Bangkok

10450

Hospital Pulau Pinang_Georgetown, Penang, George Town

19134

St Christopher Hosp for Child, Philadelphia

25100

Hospital Tengku Ampuan Afzan, Kuantan

28046

Hospital Universitario La Paz, Madrid

28204

St.Jude Clin-NovantHemby Child, Charlotte

37232

Vanderbilt Hemostasis Thrombosis Clinic, Nashville

40447

China Medical University Hospital - Children Building, Taichung

41200

Hospital Tengku Ampuan Rahimah, Klang, Selangor

44106

Univ Hosp Cleveland Med Ctr, Cleveland

46026

Hospital La Fe - Endocrinología y Nutrición, Valencia

50200

Maharaj Nakorn Chiang Mai Hospital -Pediatric Hematology and Oncology, Chiang Mai

50400

National Blood Centre, Kuala Lumpur

52621

Sheba MC - The Israeli National Hemophilia Center, Tel Litwinsky

83712

St. Luke's Mountain States Tumor Institute, Boise

84113

Univ of Utah Primary Children's Hospital, Salt Lake City

90027

Children's Hospital Los Angeles - Endocrinology, Los Angeles

70118-5720

Children's Hosp-New Orleans, New Orleans

68198-6828

Univ of NE Med Center_Omaha, Omaha

A 1090

Universitätsklinik für Kinder- und Jugendheilkunde, Vienna

L8N 3Z5

Hamltn Hth Sci/McMstr Child Hosp, Hamilton

330-8777

Saitama Children's Med Centre_Hematology-Oncology, Saitama

08950

Hospital Sant Joan de Déu, Esplugues Llobregat

LE1 5WW

Leicester Royal Infirmary - Haemostasis & Thrombosis Unit, Leicester

SE1 7EH

St Thomas' Hospital - Haemostasis and Thrombosis Centre, London

OX3 9DU

John Radcliffe Hospital, Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY