Safety and Efficacy of N8 in Haemophilia A Subjects (guardian™1)

This study has been completed.

Sponsor:

Information provided by:

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT00840086

First received: February 6, 2009

Last updated: June 29, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 6, 2009

Last Updated Date

June 29, 2012

Start Date ^ICMJE

April 2009

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The incidence rate of N8 inhibitors [ Time Frame: during 6-8 months of treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Amount of N8 used and bleeding rates and response to treatment as assessed by the physician, patient or caregiver [ Time Frame: during 6-8 months of treatment ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00840086 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Frequency of adverse events and serious adverse events reported [ Time Frame: during 6-8 months of treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Inhibitor development [ Time Frame: during 6-8 months of treatment ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of N8 in Haemophilia A Subjects

Official Title ^ICMJE

A Multi-centre, Open-label, Non-controlled Trial on Safety and Efficacy of N8 in Prevention and Treatment of Bleeds in Previously Treated Subjects With Haemophilia A. Sub-trial: Safety and Efficacy of N8 in Prevention and Treatment of Bleeding During Surgical Procedures in Subjects With Haemophilia A

Brief Summary

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

The trial consists of a main trial and a sub-trial. The main trial investigates safety and efficacy of recombinant factor VIII (N8) in haemophilia A subjects, while the sub-trial investigates safety and efficacy of N8 in prevention and treatment of bleeding during surgical procedures.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Congenital Bleeding Disorder
Haemophilia A

Intervention ^ICMJE

Drug: recombinant factor VIII (N8)
Subjects will receive bleeding preventive treatment (home treatment with self-injection i.v.) with N8 at a dose of 20-40 IU/kg body weight every second day or 20-50 IU/kg body weight three times per week at the investigator's discretion.
Other Names:
- NN7008
- rFVIII
Procedure: Blood drawn for laboratory testing
Blood drawn for laboratory testing

Study Arm (s)

Experimental: A

Interventions:

Drug: recombinant factor VIII (N8)
Procedure: Blood drawn for laboratory testing

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

150

Completion Date

September 2011

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Severe haemophilia A (FVIII level less than or equal to 1%)
Treatment history of more than 150 exposure days with recombinant or plasma-derived FVIII replacement products
Subjects can have elective surgery when at least 5 subjects have been treated with N8 for a bleeding episode and 80% of these subjects have a response rated excellent or good

Exclusion Criteria:

Presence of any bleeding disorder in addition to haemophilia A
Inhibitor titer greater than or equal to 0.6 Bethesda Units (BU) at screening and past history of inhibitor
Abnormal renal function tests
Known hypersensitivity

Gender

Male

Ages

12 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Brazil, Croatia, Germany, Israel, Italy, Japan, Malaysia, Russian Federation, Serbia, Spain, Switzerland, Taiwan, Turkey, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00840086

Other Study ID Numbers ^ICMJE

NN7008-3543, 2008-003960-20, 101151

Has Data Monitoring Committee

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:	Sofia Jonhede	Novo Nordisk
Study Director:	Anne Vedsø	Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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