Brief Title
Evaluation of Safety Following Immune Tolerance Induction Treatment With Turoctocog Alfa in Patients With Haemophilia A Following Inhibitor Development in NN7170-4213 Trial
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
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)
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Number of Adverse Events
Secondary Outcome
Response to FVIII ITI Treatment (Success, Partial Success, Failure, Other)
Condition
Haemophilia A
Intervention
Turoctocog alfa
Study Arms / Comparison Groups
Turoctocog alfa
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
1
Start Date
June 12, 2018
Completion Date
June 19, 2019
Primary Completion Date
June 19, 2019
Eligibility 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
Gender
Male
Ages
12 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Clinical Reporting Anchor and Disclosure (1452), ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT03588741
Organization ID
NN7170-4345
Secondary IDs
U1111-1187-7323
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Clinical Reporting Anchor and Disclosure (1452), Study Director, Novo Nordisk A/S
Verification Date
July 2020