Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B
NCT ID: NCT02141074
Last Updated: 2025-12-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
54 participants
INTERVENTIONAL
2014-07-02
2022-10-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
50 EDs (exposure days)
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Male, age below 6 years at the time of signing informed consent
* Patients with the diagnosis of haemophilia B (FIX (coagulation factor IX) activity level below or equal to 2%) based on medical records or central laboratory results
* Previously untreated or exposed to FIX containing products less than or equal to 3 exposure days (5 previous exposures to blood components is acceptable)
Exclusion Criteria
* Known or suspected hypersensitivity to trial product or related products
* Previous participation in this trial. Participation is defined as first dose administered of trial product
* Receipt of any investigational medicinal product within 30 days before screening
* Congenital or acquired coagulation disorder other than haemophilia B
* Any chronic disorder or severe disease which, in the opinion of the Investigator, might jeopardise the patient's safety or compliance with the protocol
* Patient's parent(s)/LAR(s) (legally acceptable representative) mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation
0 Years
6 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novo Nordisk A/S
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Miller Children's Hospital Long Beach
Long Beach, California, United States
Children's Hospital Los Angeles - Endocrinology
Los Angeles, California, United States
Shands Hospital at the University of Florida
Gainesville, Florida, United States
Nemours Chld Clnc Jacksonville
Jacksonville, Florida, United States
Augusta University
Augusta, Georgia, United States
Hope for Kids
Macon, Georgia, United States
St. Luke's Mountain States Tumor Institute
Boise, Idaho, United States
University Of Iowa
Iowa City, Iowa, United States
Children's Hosp-New Orleans
New Orleans, Louisiana, United States
Johns Hopkins University_Baltimore_3
Baltimore, Maryland, United States
Univ of NE Med Center_Omaha
Omaha, Nebraska, United States
North Shore Long Island Jewish Medical Center
New Hyde Park, New York, United States
University of North Carlolina-Chapel Hill
Chapel Hill, North Carolina, United States
Novant Hlth Vasc Ins Charlotte
Charlotte, North Carolina, United States
Univ Hosp Cleveland Med Ctr
Cleveland, Ohio, United States
Dayton Children Hemostati Ctr
Dayton, Ohio, United States
Penn State MS Hershey Med Ctr
Hershey, Pennsylvania, United States
St Christopher Hosp for Child
Philadelphia, Pennsylvania, United States
Medical University Of SC
Charleston, South Carolina, United States
Vanderbilt Hemostasis Thrombosis Clinic
Nashville, Tennessee, United States
Univ of Utah Primary Children's Hospital
Salt Lake City, Utah, United States
University of Virginia Children's Hospital
Charlottesville, Virginia, United States
Children's Hsptl Of The Kings
Norfolk, Virginia, United States
Beni Messous Hospital Issaad Hassani
Algiers, , Algeria
University Hospital Saadna Abdenour of Setif
Sétif, , Algeria
Hospital de Pediatría S.A.M.I.C. "Prof. Dr. Juan P. Garrahan
CABA, , Argentina
Sanatorio Mayo Privado S.A
Córdoba, , Argentina
Lady Cilento Children's Hospital
South Brisbane, Queensland, Australia
Royal Children's Hospital
Parkville, Victoria, Australia
Med. Univ. Graz -Klinische Abteilung f. Allgemeine Pädiatrie
Graz, , Austria
Universitätsklinik Kinder-Jugendheilkunde Innsbruck
Innsbruck, , Austria
Klinikum Klagenfurt am Wörthersee (LKH Klagenfurt)
Klagenfurt, , Austria
Landes-Frauen und Kinderklinik Linz
Linz, , Austria
LKH Salzburg- Univ. Klinik f. Kinder- und Jugendheilkunde
Salzburg, , Austria
Ordination Prof. Zwiauer
Sankt Pölten, , Austria
Universitätsklinik für Kinder- und Jugendheilkunde
Vienna, , Austria
UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Pediatrics
Plovdiv, , Bulgaria
Hamltn Hth Sci/McMstr Child Hosp
Hamilton, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
CHU Estaing
Clermont-Ferrand, , France
Ap-Hp-Hopital de Bicetre-1
Le Kremlin-Bicêtre, , France
Centre Hospitalier Universitaire de Nantes-Hopital Hotel-Dieu
Nantes, , France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes, , France
CHU Haute Pierre
Strasbourg, , France
Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie
Bonn, , Germany
Coagulation Research Center
Duisburg, , Germany
HZRM Haemophilie-Zentrum Rhein Main GmbH
Frankfurt am Main, , Germany
Werlhof-Institut
Hanover, , Germany
Aghia Sophia Childrens' Hospital
Athens, , Greece
'Ippokrateio' General Hospital of Thessaloniki
Thessaloniki, , Greece
Sheba MC - The Israeli National Hemophilia Center
Tel Litwinsky, , Israel
Dipartimento di Ematologia Univ. Firenze
Florence, , Italy
IRCCS Meyer Firenze
Florence, , Italy
Nagoya University Hospital_Blood Transfusion
Aichi, , Japan
Kanagawa Children's Medical Center _ Hematology / Oncology
Kanagawa, , Japan
Saitama Children's Med Centre_Hematology-Oncology
Saitama, , Japan
Shizuoka Children's Hospital, Hematology-Oncology
Shizuoka, , Japan
National Center for Child Health and Development_Hematology
Tokyo, , Japan
Ogikubo Hospital_Pediatries & Blood
Tokyo, , Japan
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, Malaysia
Hospital Pulau Pinang_Georgetown, Penang
George Town, Pulau Pinang, Malaysia
Hospital Tengku Ampuan Rahimah
Klang, Selangor, , Malaysia
National Blood Centre
Kuala Lumpur, , Malaysia
Centro Medico Nacional SXXI-Hospital de Pediatria, IMSS
Mexico City, México, D.F., Mexico
Hospital Universitario Dr. José Eleuterio González_Monterrey
Monterrey, Nuevo León, Mexico
Radboudumc
Nijmegen, , Netherlands
Centro Hospitalar Lisboa Norte-HSM
Lisbon, , Portugal
ULS São João, E.P.E.
Porto, , Portugal
,,Louis Ţurcanu'' Emergency Hospital for Children
Timișoara, Timiș County, Romania
1st Paediatric Department, Fundeni Clinical Institute
Bucharest, , Romania
University Children's Hospital Tirsova
Belgrade, , Serbia
Institute for Mother and Child Health Care of Serbia
Belgrade, , Serbia
Hospital Sant Joan de Déu
Esplugues Llobregat, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital La Fe - Endocrinología y Nutrición
Valencia, , Spain
Changhua Christian Hospital_Hematology Dept.
Changhua, , Taiwan
Changhua Christian Hospital
Changhua, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital_Dept of Pediatrics
Kaohsiung City, , Taiwan
China Medical University Children's Hospital
Taichung, , Taiwan
China Medical University Hospital - Children Building
Taichung, , Taiwan
National Taiwan University Children's Hospital
Taipei, , Taiwan
King Chulalongkorn Memorial Hospital_Pediatric Hematology-Oncology
Bangkok, , Thailand
Ramathibodi Hospital_Paediatrics
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital _Pediatric Hematology and Oncology
Chiang Mai, , Thailand
SI Institute of Urgent and Recovery Surgery - Haematology
Donetsk, , Ukraine
Institute of blood pathology and transfusion medicine of NAMSU - General and haematol. surgery
Lviv, , Ukraine
Birmingham Children's Hospital
Birmingham, , United Kingdom
Kent and Canterbury Hospital - Kent Haemophilia and Thrombosis Centre
Canterbury, , United Kingdom
Royal Hospital for Children
Glasgow, , United Kingdom
Leicester Royal Infirmary - Haemostasis & Thrombosis Unit
Leicester, , United Kingdom
St Thomas' Hospital - Haemostasis and Thrombosis Centre
London, , United Kingdom
Royal Manchester Children's Hospital
Manchester, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Chan AK, Alamelu J, Barnes C, Chuansumrit A, Garly ML, Meldgaard RM, Young G. Nonacog beta pegol (N9-GP) in hemophilia B: First report on safety and efficacy in previously untreated and minimally treated patients. Res Pract Thromb Haemost. 2020 Jul 29;4(7):1101-1113. doi: 10.1002/rth2.12412. eCollection 2020 Oct.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Clinical Trials at Novo Nordisk
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-004867-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1135-9557
Identifier Type: OTHER
Identifier Source: secondary_id
JapicCTI-142611
Identifier Type: REGISTRY
Identifier Source: secondary_id
NL53683.091.15
Identifier Type: OTHER
Identifier Source: secondary_id
NN7999-3895
Identifier Type: -
Identifier Source: org_study_id