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Evaluation of Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and Prophylaxis of Bleeding in Subjects With Haemophilia A

NCT ID: NCT01480180

Last Updated: 2020-11-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-30

Study Completion Date

2018-12-10

Brief Summary

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This trial is conducted globally. The aim of the trial is to evaluate the safety and efficacy, including pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in subjects with Haemophilia A.

Detailed Description

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Conditions

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Congenital Bleeding Disorder Haemophilia A

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prophylaxis

Group Type EXPERIMENTAL

turoctocog alfa pegol

Intervention Type DRUG

Administered i.v.

On-demand

Group Type EXPERIMENTAL

turoctocog alfa pegol

Intervention Type DRUG

Administered i.v.

Interventions

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turoctocog alfa pegol

Administered i.v.

Intervention Type DRUG

Other Intervention Names

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NNC 0129-0000-1003

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - Male patients with severe congenital haemophilia A (FVIII activity below 1%, according to medical records) - Documented history of at least 150 EDs (exposure days) to other FVIII products - At least 12 years and body weight at least 35 kg (except for Croatia, France, Russia, Israel and the Netherlands where the lower age limit will be 18 years) Exclusion Criteria: - Previous participation in this trial defined as withdrawal after administration N8-GP - Any history of FVIII inhibitors - FVIII inhibitors above or equal to 0.6 BU/mL at screening - HIV (human immunodeficiency virus) positive, defined by medical records with CD4+ (T-lymphocyte subtype) count below or equal to 200/mcL or a viral load of more than 400000 copies/mL. If the data is not available in medical records within last 6 months, CD4+ will be measured at the screening visit - Congenital or acquired coagulation disorders other than haemophilia A - Previous significant thromboembolic events (e.g. myocardial infarction, cerebrovascular disease or deep venous thrombosis) as defined by available medical records - Platelet count below 50,000 platelets/mcL (laboratory value at the screening visit) - ALAT (alanine aminotransferase) above 3 times the upper limit of normal reference ranges at central laboratory - Creatinine level equal to or greater than 1.5 times above upper normal limit (according to central laboratory reference ranges) - Ongoing immune modulating or chemotherapeutic medication
Minimum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Phoenix, Arizona, United States

Site Status

Novo Nordisk Investigational Site

Long Beach, California, United States

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Sacramento, California, United States

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Torrance, California, United States

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Washington D.C., District of Columbia, United States

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Washington D.C., District of Columbia, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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Augusta, Georgia, United States

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Boise, Idaho, United States

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Iowa City, Iowa, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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East Lansing, Michigan, United States

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Minneapolis, Minnesota, United States

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Omaha, Nebraska, United States

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New Brunswick, New Jersey, United States

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Newark, New Jersey, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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Charlottesville, Virginia, United States

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Norfolk, Virginia, United States

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Spokane, Washington, United States

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Camperdown, New South Wales, Australia

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South Brisbane, Queensland, Australia

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Parkville, Victoria, Australia

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Campinas, São Paulo, Brazil

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Sofia, , Bulgaria

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Split, , Croatia

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Zagreb, , Croatia

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Århus N, , Denmark

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København Ø, , Denmark

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Bron, , France

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Le Kremlin-Bicêtre, , France

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Nantes, , France

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Paris, , France

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Berlin, , Germany

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Bonn, , Germany

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Frankfurt/M., , Germany

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Hanover, , Germany

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Homburg, , Germany

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München, , Germany

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Budapest, , Hungary

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Debrecen, , Hungary

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Tel Litwinsky, , Israel

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Florence, , Italy

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Milan, , Italy

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Udine, , Italy

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Vicenza, , Italy

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Aichi, , Japan

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Hiroshima, , Japan

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Kitakyusyu, Fukuoka, , Japan

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Nara, , Japan

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Saitama, , Japan

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Shimotsuke-shi, Tochigi, , Japan

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Shizuoka, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Yokohama-shi, Kanagawa, , Japan

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Kuala Lumpur, , Malaysia

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Selangor Darul Ehsan, , Malaysia

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Groningen, , Netherlands

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Rotterdam, , Netherlands

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Oslo, , Norway

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San Juan, , Puerto Rico

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Saint Petersburg, , Russia

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Daejeon, , South Korea

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Madrid, , Spain

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Málaga, , Spain

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Malmo, , Sweden

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Geneva, , Switzerland

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Lausanne, , Switzerland

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Zurich, , Switzerland

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Changhua, , Taiwan

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Taipei, , Taiwan

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Adana, , Turkey (Türkiye)

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Bornova-IZMIR, , Turkey (Türkiye)

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Samsun, , Turkey (Türkiye)

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Basingstoke, , United Kingdom

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Cardiff, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Oxford, , United Kingdom

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Novo Nordisk Investigational Site

Sheffield, , United Kingdom

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Countries

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United States Australia Brazil Bulgaria Croatia Denmark France Germany Hungary Israel Italy Japan Malaysia Netherlands Norway Puerto Rico Russia South Korea Spain Sweden Switzerland Taiwan Turkey (Türkiye) United Kingdom

References

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Giangrande P, Chowdary P, Enhrenforth S, Hanabusa H, Leebeek FW, Lentz SR, Nemes L, Poulsen LH, Santagostino E, You CW, Clausen WHO, Oldenburg J and on behalf of for the pathfinder™2 Investigators. Clinical evaluation of novel recombinant glycopegylated FVIII (turoctocog alfa pegol, N8-GP): efficacy and safety in previously treated patients with severe hemophilia A - results of pathfinder™2 international trial. Journal of Thrombosis and Haemostasis (Abstracts) 2015; 13 (Supplement S2): 1-997 [OR212]

Reference Type RESULT

Giangrande P, Andreeva T, Chowdary P, Ehrenforth S, Hanabusa H, Leebeek FW, Lentz SR, Nemes L, Poulsen LH, Santagostino E, You CW, Clausen WH, Jonsson PG, Oldenburg J; Pathfinder2 Investigators. Clinical evaluation of glycoPEGylated recombinant FVIII: Efficacy and safety in severe haemophilia A. Thromb Haemost. 2017 Jan 26;117(2):252-261. doi: 10.1160/TH16-06-0444. Epub 2016 Dec 1.

Reference Type RESULT
PMID: 27904904 (View on PubMed)

Giangrande P, Abdul Karim F, Nemes L, You CW, Landorph A, Geybels MS, Curry N. Long-term safety and efficacy of N8-GP in previously treated adults and adolescents with hemophilia A: Final results from pathfinder2. J Thromb Haemost. 2020 Sep;18 Suppl 1(Suppl 1):5-14. doi: 10.1111/jth.14959.

Reference Type RESULT
PMID: 32544297 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1119-7416

Identifier Type: OTHER

Identifier Source: secondary_id

2011-001142-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

JapicCTI-121749

Identifier Type: OTHER

Identifier Source: secondary_id

NN7088-3859

Identifier Type: -

Identifier Source: org_study_id