Safety and Efficacy of NNC-0156-0000-0009 in Haemophilia B Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-27

Study Completion Date

2013-03-31

Brief Summary

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This trial is conducted in Africa, Asia, Europe, Japan and North America. The aim of this trial is to evaluate the safety and efficacy, including pharmacokinetics (the rate at which the body eliminates the trial drug), of NNC-0156-0000-0009 (nonacog beta pegol) when used for treatment and prophylaxis of bleeding episodes in patients with haemophilia B.

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Detailed Description

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Conditions

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Congenital Bleeding Disorder Haemophilia B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Prophylaxis, high dose (trial duration 52 weeks)

Group Type EXPERIMENTAL

nonacog beta pegol

Intervention Type DRUG

One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience

Prophylaxis, low dose (trial duration 52 weeks)

Group Type EXPERIMENTAL

nonacog beta pegol

Intervention Type DRUG

One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience

On-demand (trial duration 28 weeks)

Group Type EXPERIMENTAL

nonacog beta pegol

Intervention Type DRUG

Patients will treat themselves with either a low or a high dose dependent on the severity of the bleeding episode

Interventions

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nonacog beta pegol

One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience

Intervention Type DRUG

nonacog beta pegol

One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience

Intervention Type DRUG

nonacog beta pegol

Patients will treat themselves with either a low or a high dose dependent on the severity of the bleeding episode

Intervention Type DRUG

Other Intervention Names

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NNC-0156-0000-0009 NNC-0156-0000-0009 NNC-0156-0000-0009

Eligibility Criteria

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Inclusion Criteria

* Male patients with moderately severe or severe congenital haemophilia B with a factor IX activity of 2% or below according to medical records
* History of at least 150 exposure days to other factor IX products
* Patients currently treated on-demand with at least 6 bleeding episodes during the last 12 months or at least 3 bleeding episodes during the last 6 months, or patients currently on prophylaxis

Exclusion Criteria

* Known history of factor IX inhibitors based on existing medical records, laboratory report reviews and patient and legally acceptable representative (LAR) interviews
* HIV (Human immunodeficiency virus) positive, with a viral load equal to or above 400,000 copies/mL and/or CD4+ lymphocyte count equal to or below 200/microL
* 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)
* Immune modulating or chemotherapeutic medication

Minimum Eligible Age

13 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

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

Los Angeles, California, United States

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Novo Nordisk Investigational Site

Jacksonville, Florida, United States

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Augusta, Georgia, United States

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Iowa City, Iowa, United States

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Baltimore, Maryland, United States

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Minneapolis, Minnesota, United States

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Omaha, Nebraska, United States

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Newark, New Jersey, United States

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New York, New York, United States

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Syracuse, New York, United States

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Hershey, Pennsylvania, United States

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Houston, Texas, United States

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Edmonton, Alberta, Canada

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Le Kremlin-Bicêtre, , France

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Lyon, , France

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Bonn, , Germany

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Duisburg, , Germany

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Giessen, , Germany

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Hanover, , Germany

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Budapest, , Hungary

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Florence, , Italy

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Milan, , Italy

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Kawasaki-shi, Kanagawa, , Japan

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Nagoya-shi, Aichi, , Japan

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Nishinomiya-shi, , Japan

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Shinjuku-ku, Tokyo, , Japan

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Suginami-ku, Tokyo, , Japan

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Kuala Lumpur, , Malaysia

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Utrecht, , Netherlands

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Skopje, , North Macedonia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Parktown Johannesburg, Gauteng, South Africa

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Bangkok, , Thailand

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Ankara, , Turkey (Türkiye)

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Kayseri, , Turkey (Türkiye)

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Konya, , 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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Manchester, , United Kingdom

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Oxford, , United Kingdom

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Countries

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United States Canada France Germany Hungary Italy Japan Malaysia Netherlands North Macedonia Russia South Africa Thailand Turkey (Türkiye) United Kingdom