Evaluation of Safety Following Immune Tolerance Induction Treatment With Turoctocog Alfa in Patients With Haemophilia A Following Inhibitor Development in NN7170-4213 Trial
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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
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Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
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Tracking Information | |||||||
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First Submitted Date ICMJE | June 12, 2018 | ||||||
First Posted Date ICMJE | July 17, 2018 | ||||||
Results First Submitted Date ICMJE | June 12, 2020 | ||||||
Results First Posted Date ICMJE | July 7, 2020 | ||||||
Last Update Posted Date | July 7, 2020 | ||||||
Actual Study Start Date ICMJE | June 12, 2018 | ||||||
Actual Primary Completion Date | June 19, 2019 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
Number of Adverse Events [ Time Frame: From week 0 up to 24 months ] Count of events
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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.
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Original Secondary Outcome Measures ICMJE |
Response to immune tolerance induction (ITI) treatment within a maximum immune tolerance induction [ Time Frame: From week 0 up to 24 months ] ITI treatment response categories: success, partial success, failure, other
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | 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 ICMJE | 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) | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Haemophilia A | ||||||
Intervention ICMJE | 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. |
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Study Arms ICMJE | Experimental: Turoctocog alfa
Intervention: Drug: Turoctocog alfa
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Terminated | ||||||
Actual Enrollment ICMJE |
1 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date ICMJE | June 19, 2019 | ||||||
Actual Primary Completion Date | June 19, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 12 Years and older (Child, Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Austria, Bulgaria, France, Germany, Serbia, Turkey, United Kingdom | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03588741 | ||||||
Other Study ID Numbers ICMJE | NN7170-4345 U1111-1187-7323 ( Other Identifier: WHO ) 2016-003821-40 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Novo Nordisk A/S | ||||||
Study Sponsor ICMJE | Novo Nordisk A/S | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Novo Nordisk A/S | ||||||
Verification Date | July 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |