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Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773 | Clinical Trials | Clareo Health

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Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773

Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B

NCT01395810•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

This trial is conducted in Asia, Europe, Japan, North America and South Africa. The aim is to evaluate the safety and efficacy of nonacog beta pegol (NNC-0156-0000-0009) after long-term exposure in patients with haemophilia B. This trial is an extension to trials NN7999-3747 (NCT01333111/paradigm™ 2) and NN7999-3773 (NCT01386528/paradigm™ 3).

Eligibility

Age

13 - 70 years

Sex

MALE

Healthy Volunteers

No

Inclusion Criteria

•Previous participation in NN7999-3747 (NCT01333111) and/or NN7999-3773

Exclusion Criteria

•Known history of FIX inhibitors based on existing medical records, laboratory report reviews and patient and LAR (legal acceptable representative) interviews
•Current FIX inhibitors above or equal to 0.6 BU (Bethesda Units)
•Congenital or acquired coagulation disorders other than haemophilia B
•Previous arterial thrombotic events (e.g. myocardial infarction and intracranial thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by available medical records)
•Any disease (liver, kidney, inflammatory and mental disorders included) or condition which, according to the Investigator's (trial physician) judgement, could imply a potential hazard to the patient, interfere with trial participation, or interfere with trial outcome

Locations (49)

Novo Nordisk Investigational Site

Los Angeles, California, United States

Novo Nordisk Investigational Site

San Francisco, California, United States

Novo Nordisk Investigational Site

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

Novo Nordisk Investigational Site

Jacksonville, Florida, United States

Novo Nordisk Investigational Site

Augusta, Georgia, United States

Novo Nordisk Investigational Site

Iowa City, Iowa, United States

Novo Nordisk Investigational Site

Baltimore, Maryland, United States

Novo Nordisk Investigational Site

Minneapolis, Minnesota, United States

Novo Nordisk Investigational Site

Omaha, Nebraska, United States

Novo Nordisk Investigational Site

Newark, New Jersey, United States

Key Dates

Start Date

April 15, 2012

Primary Completion Date

March 30, 2014

Completion Date

March 30, 2014

Last Updated

May 9, 2018

Enrollment

71

ACTUAL participants

Conditions

Congenital Bleeding DisorderHaemophilia B

Interventions

nonacog beta pegol

DRUG

nonacog beta pegol

DRUG

nonacog beta pegol

DRUG

Sponsors

Lead Sponsor

Novo Nordisk A/S

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ENROLLING_BY_INVITATION

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 9, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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