Skip to main content
OpenTrials
Completed

NCT Number: NCT01392547

Efficacy and Safety of NNC 0078-0000-0007 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors

Age range

12 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Linz, Austria

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

vatreptacog alfa (activated)

Drug

1-3 doses per bleeding episode

eptacog alfa (activated)

Drug

1-3 doses per bleeding episode

Primary outcomes

  1. Effective Bleeding Control Defined as no Additional Haemostatic Medication (Other Than Trial Product) Given

    Time frame: Within 12 hours of first trial product administration

Secondary outcomes

  1. Effective and Sustained Bleeding Control

    Time frame: Up to 48 hours after first trial product administration

  2. Number of Doses of Trial Product Given for Each Acute Bleed

    Time frame: Up to 6 hours after first trial product administration

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Acronym: adept™2

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 12, 2011
Registry last updated
May 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.