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

March 29, 2017 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Scheduled dose visit in a non-bleeding state. Single dose of NNC 0078-0000-0007 (vatreptocog alfa (activated)) every 3 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, A 4020
  • Brazil
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13081970
  • Croatia
      • Zagreb, Croatia, 10 000
  • Greece
      • Athens, Greece, GR-11527
  • Hungary
      • Budapest, Hungary, H-1134
  • Italy
      • Milano, Italy, 20124
  • Japan
      • Shinjuku-ku, Tokyo, Japan, 160 0023
  • Malaysia
      • Kuala Lumpur, Malaysia, 50400
  • Poland
      • Warszawa, Poland, 02-776
  • Puerto Rico
      • San Juan, Puerto Rico, 00935
        • Novo Nordisk Clinical Trial Call Center
  • Romania
    • Timis
      • Timisoara, Timis, Romania, 300011
  • Russian Federation
      • Saint-Petersburg, Russian Federation, 191186
  • Serbia
      • Novi Sad, Serbia, 21000
  • South Africa
    • Gauteng
      • Parktown, Johannesburg, Gauteng, South Africa, 2193
  • Taiwan
      • Changhua, Taiwan, 500
  • Thailand
      • Bangkok, Thailand, 10400
  • Turkey
      • Bornova-IZMIR, Turkey, 35100
  • United Kingdom
      • Oxford, United Kingdom, OX3 7LJ
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724-0001
        • Novo Nordisk Clinical Trial Call Center
    • California
      • Los Angeles, California, United States, 90007
        • Novo Nordisk Clinical Trial Call Center
      • Los Angeles, California, United States, 90027
        • Novo Nordisk Clinical Trial Call Center
      • Orange, California, United States, 92868
        • Novo Nordisk Clinical Trial Call Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Novo Nordisk Clinical Trial Call Center
    • Florida
      • Tampa, Florida, United States, 33607
        • Novo Nordisk Clinical Trial Call Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Novo Nordisk Clinical Trial Call Center
      • Augusta, Georgia, United States, 30912
        • Novo Nordisk Clinical Trial Call Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Novo Nordisk Clinical Trial Call Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Novo Nordisk Clinical Trial Call Center
    • Michigan
      • Detroit, Michigan, United States, 48202-2608
        • Novo Nordisk Clinical Trial Call Center
    • New York
      • Brooklyn, New York, United States, 11219
        • Novo Nordisk Clinical Trial Call Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Novo Nordisk Clinical Trial Call Center
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Novo Nordisk Clinical Trial Call Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 entry

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: rFVIIa
Drug: eptacog alfa (activated)
1-3 doses per bleeding episode
Experimental: vatreptocog alfa
Drug: vatreptacog alfa (activated)
1-3 doses per bleeding episode

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Effective Bleeding Control Defined as no Additional Haemostatic Medication (Other Than Trial Product) Given
Time Frame: Within 12 hours of first trial product administration
Within 12 hours of first trial product administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effective and Sustained Bleeding Control
Time Frame: Up to 48 hours after first trial product administration
Up to 48 hours after first trial product administration
Number of Doses of Trial Product Given for Each Acute Bleed
Time Frame: Up to 6 hours after first trial product administration
Up to 6 hours after first trial product administration
Number of Adverse Events
Time Frame: Adverse events were captured from the time of consent to 1 month (+14 days) after last administration of trial product.
Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Adverse events were captured from the time of consent to 1 month (+14 days) after last administration of trial product.
Immunogenicity (Inhibitor Development)
Time Frame: Adverse events were captured from the time of consent to the end of trial visit 1 month (+14 days) after last administration of trial product.
Immunogenicity was tested by formation of neutralising antibodies towards vatreptacog alfa and/or FVII. Radioimmunoassay using [125I]-labelled vatreptacog alfa or rFVIIa was used to screen plasma samples for development of anti-drug antibodies
Adverse events were captured from the time of consent to the end of trial visit 1 month (+14 days) after last administration of trial product.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN1731-3562
  • U1111-1118-2228 (Other Identifier: WHO)
  • 2010-023803-92 (EudraCT Number)
  • JapicCTI-111595 (Registry Identifier: JAPIC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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