Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors (adept™2)

This study has been completed.

Sponsor:

Information provided by:

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT01392547

First received: July 8, 2011

Last updated: October 17, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 8, 2011

Last Updated Date

October 17, 2012

Start Date ^ICMJE

July 2011

Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Effective bleeding control defined as no additional haemostatic medication (other than trial product) given [ Time Frame: Within 12 hours of first trial product administration ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01392547 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Effective and sustained bleeding control [ Time Frame: Up to 48 hours after first trial product administration ] [ Designated as safety issue: No ]
Number of doses of trial product given for each acute bleed [ Time Frame: Up to 6 hours after first trial product administration ] [ Designated as safety issue: No ]
Number of adverse events [ Time Frame: After approximately 21 months (at end of trial) ] [ Designated as safety issue: No ]
Immunogenicity [ Time Frame: After approximately 21 months (at end of trial) ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of NNC 0078-0000-0007 in Patients With Congenital Haemophilia and Inhibitors

Official Title ^ICMJE

Efficacy and Safety of NNC 0078-0000-0007 in Treatment of Acute Bleeding Episodes in Patients With Congenital Haemophilia and Inhibitors

Brief Summary

This trial is conducted globally. The purpose of this trial is to confirm the efficacy and safety of NNC 0078-0000-0007 in patients with congenital haemophilia and inhibitors.

Detailed Description

Scheduled dose visit in a non-bleeding state. Single dose of NNC 0078-0000-0007 every 3 months

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial 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: NNC 0078-0000-0007
1-3 doses per bleeding episode
Drug: eptacog alfa (activated)
1-3 doses per bleeding episode

Study Arm (s)

Experimental: Treatment of acute bleeds (1)
Intervention: Drug: NNC 0078-0000-0007
Active Comparator: Treatment of acute bleeds (2)
Intervention: Drug: eptacog alfa (activated)

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

August 2012

Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male patient with clinical diagnosis of congenital haemophilia A or B and inhibitors to coagulation factors VIII or IX
Minimum of five bleeds requiring haemostatic drug treatment within the previous 12 months at trial start

Exclusion Criteria:

Previous participation in this trial defined as withdrawal after administration of trial product
Patient has received an investigational medicinal product within 30 days prior to this trial
Congenital or acquired coagulation disorders other than haemophilia A or B
Any clinical signs or known history of arterial thrombotic events or of deep venous thrombosis or pulmonary embolism (as defined by available medical records)
Platelet count of less than 50,000 platelets/mcL (at the screening visit)
ALAT (alanine-transaminase) of more than 3 times the upper normal limit (according to laboratory reference ranges)
Factor VIII/IX Immune Tolerance Induction regimen planned to occur during the trial
Ongoing bleeding prophylaxis regimens or planned bleeding prophylaxis to occur during the trial
HIV (Human Immunodeficiency Virus) positive with current CD4+ count of less than 200/mcL (defined by medical records)

Gender

Male

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Austria, Brazil, Croatia, Greece, Hungary, Italy, Japan, Malaysia, Poland, Puerto Rico, Romania, Russian Federation, Serbia, South Africa, Taiwan, Thailand, Turkey, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01392547

Other Study ID Numbers ^ICMJE

NN1731-3562, 2010-023803-92, U1111-1118-2228, JapicCTI-111595

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:

Tina Lund

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

October 2012

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

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