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Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors

NCT ID: NCT01392547

Last Updated: 2017-05-15

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

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-08-31

Brief Summary

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This trial is conducted globally. The purpose of this trial is to confirm the efficacy and safety of NNC 0078-0000-0007 in patients with congenital haemophilia and inhibitors.

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Detailed Description

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Scheduled dose visit in a non-bleeding state. Single dose of NNC 0078-0000-0007 (vatreptocog alfa (activated)) every 3 months.

Conditions

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Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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rFVIIa

Group Type EXPERIMENTAL

eptacog alfa (activated)

Intervention Type DRUG

1-3 doses per bleeding episode

vatreptocog alfa

Group Type EXPERIMENTAL

vatreptacog alfa (activated)

Intervention Type DRUG

1-3 doses per bleeding episode

Interventions

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vatreptacog alfa (activated)

1-3 doses per bleeding episode

Intervention Type DRUG

eptacog alfa (activated)

1-3 doses per bleeding episode

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male patient with clinical diagnosis of congenital haemophilia A or B and inhibitors to coagulation factors VIII or IX
* Minimum of five bleeds requiring haemostatic drug treatment within the previous 12 months at trial entry

Exclusion Criteria

* Previous participation in this trial defined as withdrawal after administration of trial product
* Patient has received an investigational medicinal product within 30 days prior to this trial
* Congenital or acquired coagulation disorders other than haemophilia A or B
* Any clinical signs or known history of arterial thrombotic events or of deep venous thrombosis or pulmonary embolism (as defined by available medical records)
* Platelet count of less than 50,000 platelets/mcL (at the screening visit)
* ALAT (alanine-transaminase) of more than 3 times the upper normal limit (according to laboratory reference ranges)
* Factor VIII/IX Immune Tolerance Induction regimen planned to occur during the trial
* Ongoing bleeding prophylaxis regimens or planned bleeding prophylaxis to occur during the trial
* HIV (Human Immunodeficiency Virus) positive with current CD4+ count of less than 200/mcL (defined by medical records)
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 Clinical Trial Call Center

Tucson, Arizona, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Los Angeles, California, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Los Angeles, California, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Orange, California, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Aurora, Colorado, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Tampa, Florida, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Atlanta, Georgia, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Augusta, Georgia, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Iowa City, Iowa, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Boston, Massachusetts, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Detroit, Michigan, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Brooklyn, New York, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Portland, Oregon, United States

Site Status

Novo Nordisk Clinical Trial Call Center

Richmond, Virginia, United States

Site Status

Linz, , Austria

Site Status

Campinas, São Paulo, Brazil

Site Status

Zagreb, , Croatia

Site Status

Athens, , Greece

Site Status

Budapest, , Hungary

Site Status

Milan, , Italy

Site Status

Shinjuku-ku, Tokyo, , Japan

Site Status

Kuala Lumpur, , Malaysia

Site Status

Warsaw, , Poland

Site Status

Novo Nordisk Clinical Trial Call Center

San Juan, , Puerto Rico

Site Status

Timișoara, Timiș County, Romania

Site Status

Saint Petersburg, , Russia

Site Status

Novi Sad, , Serbia

Site Status

Parktown, Johannesburg, Gauteng, South Africa

Site Status

Changhua, , Taiwan

Site Status

Bangkok, , Thailand

Site Status

Bornova-IZMIR, , Turkey (Türkiye)

Site Status

Oxford, , United Kingdom

Site Status

Countries

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United States Austria Brazil Croatia Greece Hungary Italy Japan Malaysia Poland Puerto Rico Romania Russia Serbia South Africa Taiwan Thailand Turkey (Türkiye) United Kingdom

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2010-023803-92

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1118-2228

Identifier Type: OTHER

Identifier Source: secondary_id

JapicCTI-111595

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN1731-3562

Identifier Type: -

Identifier Source: org_study_id

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