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Evaluation of Safety Following Immune Tolerance Induction Treatment With Turoctocog Alfa in Patients With Haemophilia A Following Inhibitor Development in NN7170-4213 Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03588741
Recruitment Status : Terminated (The trial was terminated as the participant withdrew from the trial.)
First Posted : July 17, 2018
Results First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to evaluate safety of immune tolerance induction (ITI) treatment with turoctocog alfa (a recombinant factor VIII) in patients who have developed neutralising antibodies against factor VIII after exposure to subcutaneous turoctocog alfa pegol during participation in NN7170-4213 (NCT02994407)

Condition or disease Intervention/treatment Phase
Haemophilia A Drug: Turoctocog alfa Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Safety Following Immune Tolerance Induction Treatment With Turoctocog Alfa in Patients With Haemophilia A Following Inhibitor Development in NN7170-4213 Trial
Actual Study Start Date : June 12, 2018
Actual Primary Completion Date : June 19, 2019
Actual Study Completion Date : June 19, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Turoctocog alfa Drug: Turoctocog alfa

Intravenous (i.v., under the skin) administration.A maximum dose of 200 IU/kg daily.

The maximum treatment period for this trial is 24 months and the patient(s) will be called for visit to the clinic every 3rd month.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: Month 0 - up to month 12 ]
    An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily have a causal relationship with this treatment.


Secondary Outcome Measures :
  1. Response to FVIII ITI Treatment (Success, Partial Success, Failure, Other) [ Time Frame: Month 12 ]
    ITI treatment response was categorized as: 1. Success: Undetectable inhibitor titre <0.6 bethesda units (BU) (or lower limit of quantification [LLoQ] if above 0.6 BU); Normalised FVIII in vivo recovery, defined as ≥0.013 international units (IU) per milliliter per IU per kilogram ((IU/ml)/(IU/kg)) (66% of expected incremental recovery); turoctocog alfa half-life ≥7 hours (based on FVIII activity) after 72 hours treatment-free washout period. 2. Partial success: Inhibitor titre ≤5 BU; Clinical effect of turoctocog alfa therapy as judged by the investigator. 3. Failure (one criterion had to be fulfilled): Failure to attain defined success or partial success after 24 months of ITI treatment with turoctocog alfa; Decrease in inhibitor titre after 12 months of ITI treatment <20% compared to peak titre. 4. Other: Participants not fulfilling the above criteria e.g. early withdrawal from ITI treatment, lack of adherence to recommended ITI protocol etc.


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previous participation in the NN7170-4213 trial (male, age at least 18 years (part A) and age at least 12 years (part B))
  • Development of a confirmed high titre neutralising antibody towards factor VIII (greater than 5 Bethesda Unit) after exposure to subcutaneous turoctocog alfa pegol in the NN7170-4213 trial or development of a confirmed clinically relevant low titre inhibitor (at least 0.6 to below or equal to 5 Bethesda Unit), defined as factor VIII activity measures (recovery) and/or bleedpattern indicating a lack of clinical response to factor VIII treatment

Exclusion Criteria:

  • Known or suspected hypersensitivity to trial product(s) or related products, defined as allergic reactions
  • Participation in another clinical trial within 1 month before screening (except participation in NN7170-4213)
  • Any disorder, except for conditions associated with Haemophilia A which in the investigator's opinion might jeopardise patients' safety or compliance with the protocol
  • Currently receiving immune tolerance induction treatment with a factor VIII containing product other than turoctocog alfa
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03588741


Locations
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Austria
Novo Nordisk Investigational Site
Wien, Austria, 1090
Bulgaria
Novo Nordisk Investigational Site
Sofia, Bulgaria, 1527
France
Novo Nordisk Investigational Site
Nantes Cedex 1, France, 44093
Germany
Novo Nordisk Investigational Site
Berlin, Germany, 10249
Novo Nordisk Investigational Site
Duisburg, Germany, 47051
Novo Nordisk Investigational Site
Homburg, Germany, 66421
Serbia
Novo Nordisk Investigational Site
Belgrade, Serbia, 11000
Novo Nordisk Investigational Site
Belgrade, Serbia, 11070
Novo Nordisk Investigational Site
Nis, Serbia, 18000
Novo Nordisk Investigational Site
Novi Sad, Serbia, 21000
Turkey
Novo Nordisk Investigational Site
Bornova-IZMIR, Turkey, 35100
United Kingdom
Novo Nordisk Investigational Site
London, United Kingdom, NW3 2QG
Novo Nordisk Investigational Site
Oxford, United Kingdom, OX3 7LJ
Novo Nordisk Investigational Site
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
  Study Documents (Full-Text)

Documents provided by Novo Nordisk A/S:
Study Protocol and Statistical Analysis Plan  [PDF] December 20, 2018

More Information
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03588741    
Other Study ID Numbers: NN7170-4345
U1111-1187-7323 ( Other Identifier: WHO )
2016-003821-40 ( EudraCT Number )
First Posted: July 17, 2018    Key Record Dates
Results First Posted: July 7, 2020
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
 Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn