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Haemophilia Patients With Inhibitors Being Treated for Acute Joint Bleeds

NCT ID: NCT00486278

Last Updated: 2017-03-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-06-30

Brief Summary

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This trial is conducted in Africa, Asia, Europe, Japan, and North and South America.

The aim of this trial is to evaluate the safety and efficacy of activated recombinant human factor VII analogue (vatreptocog alfa (activated)) in haemophilia patients with inhibitors.

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Detailed Description

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Conditions

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Congenital Bleeding Disorder Haemophilia A Haemophilia B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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vatreptacog alfa 5 mcg/kg

Group Type EXPERIMENTAL

vatreptacog alfa (activated)

Intervention Type DRUG

5 mcg/kg, injected i.v.

vatreptacog alfa 10 mcg/kg

Group Type EXPERIMENTAL

vatreptacog alfa (activated)

Intervention Type DRUG

10 mcg/kg, injected i.v.

vatreptacog alfa 20 mcg/kg

Group Type EXPERIMENTAL

vatreptacog alfa (activated)

Intervention Type DRUG

20 mcg/kg, injected i.v.

vatreptacog alfa 40 mcg/kg

Group Type EXPERIMENTAL

vatreptacog alfa (activated)

Intervention Type DRUG

40 mcg/kg, injected i.v.

vatreptacog alfa 80 mcg/kg

Group Type EXPERIMENTAL

vatreptacog alfa (activated)

Intervention Type DRUG

80 mcg/kg, injected i.v.

rFVIIa 90 mcg/kg

Group Type EXPERIMENTAL

eptacog alfa (activated)

Intervention Type DRUG

90 mcg/kg, injected i.v.

Interventions

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eptacog alfa (activated)

90 mcg/kg, injected i.v.

Intervention Type DRUG

vatreptacog alfa (activated)

5 mcg/kg, injected i.v.

Intervention Type DRUG

vatreptacog alfa (activated)

10 mcg/kg, injected i.v.

Intervention Type DRUG

vatreptacog alfa (activated)

20 mcg/kg, injected i.v.

Intervention Type DRUG

vatreptacog alfa (activated)

40 mcg/kg, injected i.v.

Intervention Type DRUG

vatreptacog alfa (activated)

80 mcg/kg, injected i.v.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 12 years of age or older (at least 18 years in Croatia, France and United Kingdom (UK))
* Clinical diagnosis of congenital haemophilia A or B with a current positive inhibitor titre and a known peak inhibitor of above 5 Bethesda units (BU) (present or in the past) to human FVIII or IX and known antihuman FVIII or IX anamnestic response
* Minimum of 2 joint bleeds (haemarthroses of ankles, knees, or elbows) requiring haemostatic drug treatment within the previous 6 months, or at least 4 joint bleeds (hemarthroses of ankles, knees, or elbows) requiring haemostatic drug treatment within the previous 12 months at trial entry

Exclusion Criteria

* Known allergy to rFVIIa, and/or suspected allergy to trial product
* Platelet count lower than 50,000 mm\^3 based on medical records at trial entry (visit 1)
* Any clinical signs or history of thromboembolic events
* Advanced atherosclerotic disease
* Severe liver disease based on medical records within the past 12 months at trial entry (Visit 1), as defined by alanine aminotransferase (ALAT) above 3 times the upper limit of normal reference range
* Known active pseudo tumours (documented bleeding requiring treatment within the last 3 months
* Subject had any (major) surgical procedure in the 30 days prior to screening into the trial. a. Catheter, ports and dental extractions do not count as surgeries and will not exclude the subject
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

Los Angeles, California, United States

Site Status

Novo Nordisk Investigational Site

Augusta, Georgia, United States

Site Status

Novo Nordisk Investigational Site

Chicago, Illinois, United States

Site Status

Novo Nordisk Investigational Site

Indianapolis, Indiana, United States

Site Status

Novo Nordisk Investigational Site

Iowa City, Iowa, United States

Site Status

Novo Nordisk Investigational Site

Boston, Massachusetts, United States

Site Status

Novo Nordisk Investigational Site

Ann Arbor, Michigan, United States

Site Status

Novo Nordisk Investigational Site

Minneapolis, Minnesota, United States

Site Status

Novo Nordisk Investigational Site

New York, New York, United States

Site Status

Novo Nordisk Investigational Site

Chapel Hill, North Carolina, United States

Site Status

Novo Nordisk Investigational Site

Cincinnati, Ohio, United States

Site Status

Novo Nordisk Investigational Site

Portland, Oregon, United States

Site Status

Novo Nordisk Investigational Site

Ciudad Autónoma de Bs. As., , Argentina

Site Status

Novo Nordisk Investigational Site

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Novo Nordisk Investigational Site

Campinas, São Paulo, Brazil

Site Status

Novo Nordisk Investigational Site

São Paulo, , Brazil

Site Status

Novo Nordisk Investigational Site

Edmonton, Alberta, Canada

Site Status

Novo Nordisk Investigational Site

Zagreb, , Croatia

Site Status

Novo Nordisk Investigational Site

Lyon, , France

Site Status

Novo Nordisk Investigational Site

Budapest, , Hungary

Site Status

Novo Nordisk Investigational Site

Debrecen, , Hungary

Site Status

Novo Nordisk Investigational Site

Tel Litwinsky, , Israel

Site Status

Novo Nordisk Investigational Site

Castelfranco Veneto, , Italy

Site Status

Novo Nordisk Investigational Site

Florence, , Italy

Site Status

Novo Nordisk Investigational Site

Milan, , Italy

Site Status

Novo Nordisk Investigational Site

Hiroshima-shi, Hiroshima, , Japan

Site Status

Novo Nordisk Investigational Site

Itabashi-ku, Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Kashihara-shi, Nara, , Japan

Site Status

Novo Nordisk Investigational Site

Nagoya-shi, Aichi, , Japan

Site Status

Novo Nordisk Investigational Site

Nishinomiya-shi, , Japan

Site Status

Novo Nordisk Investigational Site

Kuala Lumpur, , Malaysia

Site Status

Novo Nordisk Investigational Site

Warsaw, , Poland

Site Status

Novo Nordisk Investigational Site

Parktown Johannesburg, Gauteng, South Africa

Site Status

Novo Nordisk Investigational Site

Durban, KwaZulu-Natal, South Africa

Site Status

Novo Nordisk Investigational Site

Cape Town, , South Africa

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Changhua, , Taiwan

Site Status

Novo Nordisk Investigational Site

Taipei, , Taiwan

Site Status

Novo Nordisk Investigational Site

Bangkok, , Thailand

Site Status

Novo Nordisk Investigational Site

Adana, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Ankara, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Antalya, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Bornova-IZMIR, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

London, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Manchester, , United Kingdom

Site Status

Countries

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United States Argentina Brazil Canada Croatia France Hungary Israel Italy Japan Malaysia Poland South Africa Spain Taiwan Thailand Turkey (Türkiye) United Kingdom

References

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de Paula EV, Kavakli K, Mahlangu J, Ayob Y, Lentz SR, Morfini M, Nemes L, Salek SZ, Shima M, Windyga J, Ehrenforth S, Chuansumrit A; 1804 (adept(TM)1) Investigators. Recombinant factor VIIa analog (vatreptacog alfa [activated]) for treatment of joint bleeds in hemophilia patients with inhibitors: a randomized controlled trial. J Thromb Haemost. 2012 Jan;10(1):81-9. doi: 10.1111/j.1538-7836.2011.04549.x.

Reference Type RESULT
PMID: 22470921 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2006-004879-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CTI-080612

Identifier Type: OTHER

Identifier Source: secondary_id

NN1731-1804

Identifier Type: -

Identifier Source: org_study_id

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