Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia

This study has been completed.

Sponsor:

Information provided by:

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT00108758

First received: April 18, 2005

Last updated: May 24, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 18, 2005

Last Updated Date

May 24, 2012

Start Date ^ICMJE

March 2004

Primary Completion Date

November 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Reduction of bleeds [ Time Frame: During 3 months treatment period as compared to 3 months observation period ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Efficacy

Change History

Complete list of historical versions of study NCT00108758 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Efficacy variables [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia

Official Title ^ICMJE

Exploratory, Multi-centre, Randomised, Double-blind, Uncontrolled Trial Evaluating the Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Secondary Bleeding Prophylaxis in Congenital Haemophilia A or B Patients With Inhibitors

Brief Summary

This trial is conducted in Africa, Asia, Europe, South America, and the United States of America (USA).

The purpose of this study is to evaluate the effectiveness of secondary prophylactic treatment with NovoSeven® in haemophilia A and B patients with inhibitors.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Congenital Bleeding Disorder
Haemophilia A With Inhibitors
Haemophilia B With Inhibitors

Intervention ^ICMJE

Drug: activated recombinant human factor VII

Study Arm (s)

Not Provided

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

Completion Date

November 2005

Primary Completion Date

November 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of congenital haemophilia A or B with inhibitors development against FVIII or FIX, respectively

Exclusion Criteria:

Prophylactic administration of any haemostatic drug within 3 last months prior to entering the trial.

Gender

Male

Ages

2 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Argentina, Brazil, Bulgaria, Philippines, Poland, Romania, Russian Federation, South Africa, Spain, Turkey

Administrative Information

NCT Number ^ICMJE

NCT00108758

Other Study ID Numbers ^ICMJE

F7HAEM-1505

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:

Ute Friedrich, PhD

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

May 2012

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

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